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Director, Clinical Development, Neuroscience

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description The Director, Clinical Development, will join a growing team in the therapeutic areas of Neuroscience. Responsibilities include clinical leadership of development programs, medical monitoring of clinical trials (if MD), contributing to CNS clinical development strategy, supporting regulatory submissions, and representing clinical development in multidisciplinary teams within R&D. Essential Functions Provide leadership and medical/scientific input for clinical programs, clinical protocols in development, ongoing clinical trials (Phase 2, Phase 3) , clinical study reports and regulatory documents. Serve as medical monitor on trials for products under development in CNS/neurology (if MD or appropriate per role). Provide clinical oversight during clinical programs and make recommendations based on findings to team, as needed. Provide strategic input on new product concepts, long-range strategic plans and licensing opportunities in CNS. Collaborate closely within clinical development and with cross-functional team members including in clinical operations, regulatory affairs, drug safety and pharmacovigilance, and quality to facilitate the execution of phase 2 and phase 3 clinical trials and programs. Collaborate closely with study investigators on clinical trial eligibility and subject and patient safety issues. Engage external experts to obtain scientific input into clinical program development. Prepare clinical data and clinical program presentations Review, interpret, and approve safety and efficacy data in clinical study reports, regulatory documents and submissions related to clinical trials (e.g., IND and NDA). Review publication-related materials on Jazz Pharmaceuticals sponsored studies. Required Knowledge, Skills, and Abilities Clinical/scientific research experience required, with neuroscience expertise, epilepsy expertise preferred. Experience working in a pharma/biotech company, CRO, or other clinical research related vendor preferred. Ability to effectively lead cross functional teams and successfully leverage internal and external partnerships Experience in preparation of regulatory submissions (INDs and NDAs) to US and European regulatory agencies. Lead preparation of clinical portions of relevant regulatory documents. Excellent oral and written communication skills. Knowledge of GCP, drug safety, MedDRA safety coding, and pharmacovigilance processes (as appropriate per role). Collaborative and flexible in personal interactions at all levels of the company. Ability to train other physicians/scientists a plus. Ability to work proactively and effectively, with demonstrated creative problem solving skills. Travel required (up to 5-20% of time) Required/Preferred Education and Licenses Medical degree, MD or advanced degree in biological sciences e.g. PhD or Pharm D with drug development experience in Neuroscience, e xperience in epilepsy is highly advantageous. Board Certification in Neurology, or equivalent CNS training is required US licensure and/or clinical practice experience preferred US licensure and/or clinical practice experience preferred Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $196,000.00 - $294,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • Middle West, PA

  • no content

Medical Director, Medical Safety

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. Essential Functions Job Responsibilities and Requirements: Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s. Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team. Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective. Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling. Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed. Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Participate in or Lead a Safety Management Team (SMT) for an assigned product. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s. Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements. Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data. Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards. Provide safety expertise to due diligence activities, if/ as needed. Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities. Required Knowledge, Skills, and Abilities Minimum Requirements Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered. Excellent knowledge of drug development process. Requires a high level of initiative and independence. Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork. Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word. Some national/international travel may be required. Leadership Skills Enterprise and Proactive Mindset-demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment. Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change. Inspire & Mobilize Others: Serve as a positive role model - create followership and effectively mobilize and influence others, both on your teams and across the organization. Understanding of target product profile; clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP). Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred. Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus. MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus. Ability to manage multiple tasks with deadlines in fast-pace environment. Required/Preferred Education and Licenses MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $256,000.00 - $384,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • Carlsbad, CA

  • no content

Senior Director, Oncology Pharmacology

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description This individual will be responsible for leading scientific team members assigned to oncology assets ranging from discovery through regulatory approval. This individual will both manage the oncology pharmacology team and serve a lead on one or more programs themselves. Primary responsibilities of the oncology pharmacology team include establishing efficacy in relevant disease models, demonstrating differentiation relative to relevant comparators, determining PK/PD/efficacy relationships, characterizing mechanisms of action, identifying predictive disease models, indications, and biomarkers, driving preclinical discovery, supporting research and development of Jazz products and drug candidates overall, and designing and executing studies that address clinically relevant priorities. Operational tasks include designing and executing experiments that are outsourced or performed by in-house bench researchers or academic collaborators, reviewing and contributing to clinical protocols, reviewing and authoring technical reports, coauthoring sections of regulatory documents ranging from IND to NDA/BLA submissions, and communicating relevant research at internal and external forums. The oncology pharmacology team cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management. Collaborate with and represent ORP on internal teams-to design, develop, implement, and oversee execution of strategies and experiments supporting nonclinical studies in hematologic malignancies and solid tumors. Essential Functions Design and execute experiments to elucidate efficacy, tolerability, mechanism of action, and biomarkers associated with complex combinations of multiple therapeutic modalities (small molecules, biologics, ADCs, bi-specifics, cell therapies, and other emerging platforms). Critically evaluate biochemical and cellular assays. Communicate effectively across JAZZ functional teams, highly matrixed, cross functional environments. Demonstrate strong interpersonal, negotiation, and influence skills. Independently develop experimental strategies, analyze data, and present results to non clinical and governance-level teams. Collaborate with CROs to outsource studies, develop protocols, manage timelines and budgets, and partner with academic labs for Jazz sponsored research. Serve as a project team leader and/or as lead pharmacology representative across various oncology programs, Mentor junior scientists and providing scientific leadership and professional growth opportunities. Required Knowledge, Skills, and Abilities Industry experience evaluating therapeutic potential of drug candidates from hit to lead optimization through IND enabling studies, with deep expertise in oncology drug development. Broad background in preclinical oncology with strong familiarity with emerging therapeutic modalities, competitive landscapes, and strategic assessment of diverse drug mechanisms. Extensive experience in Immuno Oncology (I/O), including I/O relevant in vivo and in vitro models, immune cell biology, and integration of immunological endpoints into pharmacology programs. Demonstrated experience working across multiple drug modalities, including small molecules, biologics, ADCs, bi-specifics, T cell engagers, cell and gene therapies, and RNA based therapeutics. Strong foundational understanding of the interdependencies between Nonclinical Pharmacology, Toxicology, DMPK, and Clinical Pharmacology, including how these functions integrate to enable successful dose selection, therapeutic index characterization, risk assessment, and translational strategy. Deep understanding of cancer signaling pathways and their therapeutic exploitation. Proven experience leading multiple complex pharmacology programs at diverse CROs, including GLP and non-GLP environments. Expertise designing and executing studies evaluating efficacy, tolerability, mechanism of action, and biomarker strategies for small molecule and biologic agents. Ability to integrate preclinical and clinical datasets, innovate, and apply novel methodologies to advance therapeutic programs. Proficiency with analytical tools (e.g., GraphPad Prism) and biomarker data analysis. Direct people management experience, including mentorship, performance development, and leadership of scientific teams. Strong leadership qualities, self motivation, and demonstrated success networking across internal teams, academia, industry, and regulatory agencies. Excellent ability to assess program needs, oversee CRO activities, develop/review protocols, monitor execution, interpret results, and prepare high quality reports for regulatory submissions. Experience authoring nonclinical components of IND, NDA/BLA/MAA submissions, briefing packages, DSURs, IBs, and fast track designation documents, with proven ability to ensure alignment and scientific rigor. Strong project management skills with the ability to manage multiple complex programs simultaneously. Demonstrated success leading in fast paced, highly matrixed environments, aligning diverse stakeholders and driving decision making. Strong analytical and creative problem-solving skills. Embody and model Jazz core values. Required/Preferred Education and Licenses Ph.D. in biology, biochemistry, immunology, pharmacology, or a related discipline, with experience leading early oncology programs and developing nonclinical models for characterizing therapeutic efficacy and pharmacodynamics, including substantial oncology and immuno-oncology experience. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $232,000.00 - $348,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • Middle West, PA

  • no content

Associate Medical Director, Medical Safety

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. 1 Essential Functions/Responsibilities The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout its lifecycle. This includes generating all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. • Provide Medical Safety/PV inputs to the assigned products at Jazz Pharmaceuticals, which may include Clinical Development program of all phases, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence • Provide Medical safety/PV inputs to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products • Participate in the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts, journal articles and other documents as needed, ensuring safety profile reflected for assigned products • Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and with the Jazz Labeling Committee ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling • Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed • Conduct signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders • Chair the Safety Management Team (SMT) of products under authority and participate in other executive forums for assigned products • Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products • Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements • Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; active involvement in inspection readiness activities, internal audits and external inspections • Represent PV in cross-functional forums and committees involving products under responsibility to achieve the Company's goals • Contribute to key performance indicators to ensure PV excellence • Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities 2 Required Knowledge, Skills, and Abilities • Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas and European Union, territories including an understanding of case processing procedures and other pharmacovigilance processes • Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems • MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries • Working experience with PV audit process with active participation in Regulatory Authority Inspections is preferred • Ability to manage multiple tasks with deadlines in fast-paced working environment • Knowledge of drug development process • Requires a high level of initiative and independence • Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork • Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word • Some national/international travel may be required 3 Required/Preferred Education and Licenses • MD required (or equivalent); medical licensure in at least one state preferred; clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus • Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience. Other relevant experience may be considered Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $212,000.00 - $318,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • Middle West, PA

  • no content

Senior Principal Real World Analyst (RWA)-2

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Senior Principal Real-World Analyst (RWA) will be responsible for conducting analyses for Real-World Evidence (RWE) studies and analytic projects using diverse Real-World Data (RWD) sources including administrative claims, electronic medical records (EMR), and registry data. Reporting to the head of RWD/A, and positioned within the RWE/A, Global Evidence & Value Generation department, the successful candidate will demonstrate deep expertise in RWD analytics, exceptional programming and analytical capabilities, strong organizational skills and a keen eye for detail, and a proven record of delivering high-quality RWE projects. In addition, the candidate will be responsible for ensuring the timely completion and scientific rigor of all research outputs. Essential Functions/Responsibilities Conduct and audit RWE analyses using a variety of RWD from multiple sources Work collaboratively with the RWA lead and other team members to meet study and recurring report timelines Leverage advanced statistical and epidemiological methodologies to deliver robust and reliable results Clean and validate RWD and outputs for consistency and reliability Maintain clear documentation of analytical programming codes and operational definitions to ensure reproducible and auditable RWE studies/analytic projects Develop reports, presentations and dashboards to communicate complex data insights Provide support in designing and enforcing RWA standards that improve operational efficiency and guarantee accuracy in RWE studies/analytic projects Stay current with evolving RWA methodologies, emerging data visualization technologies, and established industry best practices Required Knowledge, Skills, and Abilities MS or PhD in data science, epidemiology, statistics, public health, or related discipline Relevant experience (4 years for MS, 2years for PhD) within biopharma companies, RWE consulting firms, or other relevant healthcare industries Demonstrated expertise with multiple RWD sources, with extensive hands-on experience working with Flatiron and Optum data (minimum 2 years) required Expert proficiency in programming software SQL and R is required. Knowledge of Python would be considered an advantage Familiarity with US and global health care coding system (e.g. ICD, CPT, HCPCS, LOINC, MedDRA) and delivery system (e.g. payers and reimbursement models) Experience conducting routine and advanced statistical analyses for RWE generation, leveraging time-to-event, cross-sectional, and longitudinal data Experience with big data analytical platforms (e.g., Snowflake). Knowledge of data visualization tools (e.g., PowerBI) would be considered an advantage Relevant experience (4 years for MS, 2years for PhD) within biopharma companies, RWE consulting firms, or other relevant healthcare industries Highly motivated and intellectually curious, with strong executional rigor and a passion for solving complex challenges Able to work in a fast-paced, flexible, team-oriented environment Required/Preferred Education and Licenses MS or PhD in data science, epidemiology, statistics, public health, or related discipline Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $151,200.00 - $226,800.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • Middle West, PA

  • no content

Senior Manager, Pipeline Innovation

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: This person will join the R&D Pipeline Innovation team which is a key component Jazz Corporate Development. R&D Pipeline Innovation provides insightful, timely, and decision enabling R&D assessment of potential new Jazz Pharmaceuticals investment opportunities such as Mergers and Acquisitions or in-licensing of investigational new drugs or marketed drug products. As a member of this team, this person will work closely with the R&D functions (e.g., Research, Early Development, Clinical Development, Clinical Operations, Project Management, Regulatory, Quality, Safety and Pharmacovigilance), as well as with New Product Planning (responsible for the commercial assessment), and the rest of the Corporate Development team to identify and assess potential business development and licensing (BD&L) opportunities in neuroscience. Essential Functions Job Functions: This position has varying responsibilities relating to identification and technical assessment of potential new BD&L opportunities in both neuroscience and oncology: Supports Jazz's efforts to identify new BD&L opportunities by: Maintaining Jazz databases of target opportunities and historical record of previous evaluations Conducting disease landscape evaluations leveraging internal databases and with external vendors Proactively monitoring industry changes/trends, conferences and the scientific literature Supporting other data gatherings and analytics Traveling to external conferences and meetings (10% - 20% of working hours) Supports Jazz's diligence and technical assessment of opportunities by: Supporting the Pipeline Innovation deal lead in coordinating R&D diligence with the relevant functions (e.g., Research, Early Development, Clinical Development, Clinical Operations, Project Management, Regulatory, Quality, Safety and Pharmacovigilance) Supporting initial and timely technical evaluation of these opportunities from a drug development perspective (including: mechanistic rationale, preclinical evidence, clinical utility, regulatory feasibility) and business perspective (including: unmet need assessment, competitive landscape, strategic fit) Working closely with Pipeline Innovation deal lead as well as New Product Planning and the Corporate Development team to synthesize technical findings into overall recommendations Tracking and summarizing technical evaluation of opportunities and generating diligence summary documents Regularly interacting with and presenting to senior leadership regarding diligence findings Representing Jazz Pharmaceuticals R&D in interactions with KOLs, companies, academic institutions or other entities pursuant to above responsibilities Take responsibility for KOL contract management while contributing to outreach efforts and network expansion Support Jazz's R&D by: Maintaining the quarterly RNCD pipeline prioritization scoresheet to facilitate strategic decision-making. Support regular neuroscience and oncology Advisory Boards. undefined Required Knowledge, Skills, and Abilities Job Requirements Ph.D. required with a good understanding of molecular biology 2 or more years of experience in pharmaceutical or biotechnology research, business development, or consulting industry, demonstrating a broad understanding of drug development Excellent communication skills, both verbal and written Experience creating recommendations and presenting to a team in an industry setting Experience managing datasets (e.g., in excel spreadsheets) Ability to work collaboratively with a wide range of people and personalities, from different functions, geographies, and backgrounds Ability to think critically, anticipate and solve problems creatively Ability to navigate and be successful in a fast-paced, highly-matrixed work environment Eager to learn from subject matter experts across numerous aspects of drug development Embody and model Jazz Pharmaceuticals core values Required/Preferred Education and Licenses Ph.D. required with a good understanding of molecular biology 3 or more years of experience in pharmaceutical or biotechnology research, business development, or consulting industry, demonstrating a broad understanding of drug development Experience in oncology preferred Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $144,000.00 - $216,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • Middle West, PA

  • no content

Senior Director, Oncology Pharmacology

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description This individual will be responsible for leading scientific team members assigned to oncology assets ranging from discovery through regulatory approval. This individual will both manage the oncology pharmacology team and serve a lead on one or more programs themselves. Primary responsibilities of the oncology pharmacology team include establishing efficacy in relevant disease models, demonstrating differentiation relative to relevant comparators, determining PK/PD/efficacy relationships, characterizing mechanisms of action, identifying predictive disease models, indications, and biomarkers, driving preclinical discovery, supporting research and development of Jazz products and drug candidates overall, and designing and executing studies that address clinically relevant priorities. Operational tasks include designing and executing experiments that are outsourced or performed by in-house bench researchers or academic collaborators, reviewing and contributing to clinical protocols, reviewing and authoring technical reports, coauthoring sections of regulatory documents ranging from IND to NDA/BLA submissions, and communicating relevant research at internal and external forums. The oncology pharmacology team cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management. Collaborate with and represent ORP on internal teams-to design, develop, implement, and oversee execution of strategies and experiments supporting nonclinical studies in hematologic malignancies and solid tumors. Essential Functions Design and execute experiments to elucidate efficacy, tolerability, mechanism of action, and biomarkers associated with complex combinations of multiple therapeutic modalities (small molecules, biologics, ADCs, bi-specifics, cell therapies, and other emerging platforms). Critically evaluate biochemical and cellular assays. Communicate effectively across JAZZ functional teams, highly matrixed, cross functional environments. Demonstrate strong interpersonal, negotiation, and influence skills. Independently develop experimental strategies, analyze data, and present results to non clinical and governance-level teams. Collaborate with CROs to outsource studies, develop protocols, manage timelines and budgets, and partner with academic labs for Jazz sponsored research. Serve as a project team leader and/or as lead pharmacology representative across various oncology programs, Mentor junior scientists and providing scientific leadership and professional growth opportunities. Required Knowledge, Skills, and Abilities Industry experience evaluating therapeutic potential of drug candidates from hit to lead optimization through IND enabling studies, with deep expertise in oncology drug development. Broad background in preclinical oncology with strong familiarity with emerging therapeutic modalities, competitive landscapes, and strategic assessment of diverse drug mechanisms. Extensive experience in Immuno Oncology (I/O), including I/O relevant in vivo and in vitro models, immune cell biology, and integration of immunological endpoints into pharmacology programs. Demonstrated experience working across multiple drug modalities, including small molecules, biologics, ADCs, bi-specifics, T cell engagers, cell and gene therapies, and RNA based therapeutics. Strong foundational understanding of the interdependencies between Nonclinical Pharmacology, Toxicology, DMPK, and Clinical Pharmacology, including how these functions integrate to enable successful dose selection, therapeutic index characterization, risk assessment, and translational strategy. Deep understanding of cancer signaling pathways and their therapeutic exploitation. Proven experience leading multiple complex pharmacology programs at diverse CROs, including GLP and non-GLP environments. Expertise designing and executing studies evaluating efficacy, tolerability, mechanism of action, and biomarker strategies for small molecule and biologic agents. Ability to integrate preclinical and clinical datasets, innovate, and apply novel methodologies to advance therapeutic programs. Proficiency with analytical tools (e.g., GraphPad Prism) and biomarker data analysis. Direct people management experience, including mentorship, performance development, and leadership of scientific teams. Strong leadership qualities, self motivation, and demonstrated success networking across internal teams, academia, industry, and regulatory agencies. Excellent ability to assess program needs, oversee CRO activities, develop/review protocols, monitor execution, interpret results, and prepare high quality reports for regulatory submissions. Experience authoring nonclinical components of IND, NDA/BLA/MAA submissions, briefing packages, DSURs, IBs, and fast track designation documents, with proven ability to ensure alignment and scientific rigor. Strong project management skills with the ability to manage multiple complex programs simultaneously. Demonstrated success leading in fast paced, highly matrixed environments, aligning diverse stakeholders and driving decision making. Strong analytical and creative problem-solving skills. Embody and model Jazz core values. Required/Preferred Education and Licenses Ph.D. in biology, biochemistry, immunology, pharmacology, or a related discipline, with experience leading early oncology programs and developing nonclinical models for characterizing therapeutic efficacy and pharmacodynamics, including substantial oncology and immuno-oncology experience. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $232,000.00 - $348,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • East Palo Alto, CA

  • no content

Medical Director, Medical Safety

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. Essential Functions Job Responsibilities and Requirements: Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s. Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team. Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective. Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling. Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed. Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Participate in or Lead a Safety Management Team (SMT) for an assigned product. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s. Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements. Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data. Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards. Provide safety expertise to due diligence activities, if/ as needed. Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities. Required Knowledge, Skills, and Abilities Minimum Requirements Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered. Excellent knowledge of drug development process. Requires a high level of initiative and independence. Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork. Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word. Some national/international travel may be required. Leadership Skills Enterprise and Proactive Mindset-demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment. Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change. Inspire & Mobilize Others: Serve as a positive role model - create followership and effectively mobilize and influence others, both on your teams and across the organization. Understanding of target product profile; clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP). Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred. Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus. MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus. Ability to manage multiple tasks with deadlines in fast-pace environment. Required/Preferred Education and Licenses MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $256,000.00 - $384,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • Middle West, PA

  • no content

Senior Manager, Pipeline Innovation

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: This person will join the R&D Pipeline Innovation team which is a key component Jazz Corporate Development. R&D Pipeline Innovation provides insightful, timely, and decision enabling R&D assessment of potential new Jazz Pharmaceuticals investment opportunities such as Mergers and Acquisitions or in-licensing of investigational new drugs or marketed drug products. As a member of this team, this person will work closely with the R&D functions (e.g., Research, Early Development, Clinical Development, Clinical Operations, Project Management, Regulatory, Quality, Safety and Pharmacovigilance), as well as with New Product Planning (responsible for the commercial assessment), and the rest of the Corporate Development team to identify and assess potential business development and licensing (BD&L) opportunities in neuroscience. Essential Functions Job Functions: This position has varying responsibilities relating to identification and technical assessment of potential new BD&L opportunities in both neuroscience and oncology: Supports Jazz's efforts to identify new BD&L opportunities by: Maintaining Jazz databases of target opportunities and historical record of previous evaluations Conducting disease landscape evaluations leveraging internal databases and with external vendors Proactively monitoring industry changes/trends, conferences and the scientific literature Supporting other data gatherings and analytics Traveling to external conferences and meetings (10% - 20% of working hours) Supports Jazz's diligence and technical assessment of opportunities by: Supporting the Pipeline Innovation deal lead in coordinating R&D diligence with the relevant functions (e.g., Research, Early Development, Clinical Development, Clinical Operations, Project Management, Regulatory, Quality, Safety and Pharmacovigilance) Supporting initial and timely technical evaluation of these opportunities from a drug development perspective (including: mechanistic rationale, preclinical evidence, clinical utility, regulatory feasibility) and business perspective (including: unmet need assessment, competitive landscape, strategic fit) Working closely with Pipeline Innovation deal lead as well as New Product Planning and the Corporate Development team to synthesize technical findings into overall recommendations Tracking and summarizing technical evaluation of opportunities and generating diligence summary documents Regularly interacting with and presenting to senior leadership regarding diligence findings Representing Jazz Pharmaceuticals R&D in interactions with KOLs, companies, academic institutions or other entities pursuant to above responsibilities Take responsibility for KOL contract management while contributing to outreach efforts and network expansion Support Jazz's R&D by: Maintaining the quarterly RNCD pipeline prioritization scoresheet to facilitate strategic decision-making. Support regular neuroscience and oncology Advisory Boards. undefined Required Knowledge, Skills, and Abilities Job Requirements Ph.D. required with a good understanding of molecular biology 2 or more years of experience in pharmaceutical or biotechnology research, business development, or consulting industry, demonstrating a broad understanding of drug development Excellent communication skills, both verbal and written Experience creating recommendations and presenting to a team in an industry setting Experience managing datasets (e.g., in excel spreadsheets) Ability to work collaboratively with a wide range of people and personalities, from different functions, geographies, and backgrounds Ability to think critically, anticipate and solve problems creatively Ability to navigate and be successful in a fast-paced, highly-matrixed work environment Eager to learn from subject matter experts across numerous aspects of drug development Embody and model Jazz Pharmaceuticals core values Required/Preferred Education and Licenses Ph.D. required with a good understanding of molecular biology 3 or more years of experience in pharmaceutical or biotechnology research, business development, or consulting industry, demonstrating a broad understanding of drug development Experience in oncology preferred Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $144,000.00 - $216,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • Carlsbad, CA

  • no content

Associate Medical Director, Medical Safety

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. 1 Essential Functions/Responsibilities The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout its lifecycle. This includes generating all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. • Provide Medical Safety/PV inputs to the assigned products at Jazz Pharmaceuticals, which may include Clinical Development program of all phases, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence • Provide Medical safety/PV inputs to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products • Participate in the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts, journal articles and other documents as needed, ensuring safety profile reflected for assigned products • Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and with the Jazz Labeling Committee ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling • Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed • Conduct signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders • Chair the Safety Management Team (SMT) of products under authority and participate in other executive forums for assigned products • Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products • Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements • Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; active involvement in inspection readiness activities, internal audits and external inspections • Represent PV in cross-functional forums and committees involving products under responsibility to achieve the Company's goals • Contribute to key performance indicators to ensure PV excellence • Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities 2 Required Knowledge, Skills, and Abilities • Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas and European Union, territories including an understanding of case processing procedures and other pharmacovigilance processes • Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems • MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries • Working experience with PV audit process with active participation in Regulatory Authority Inspections is preferred • Ability to manage multiple tasks with deadlines in fast-paced working environment • Knowledge of drug development process • Requires a high level of initiative and independence • Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork • Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word • Some national/international travel may be required 3 Required/Preferred Education and Licenses • MD required (or equivalent); medical licensure in at least one state preferred; clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus • Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience. Other relevant experience may be considered Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $212,000.00 - $318,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • East Palo Alto, CA

  • no content

Associate Medical Director, Medical Safety

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. 1 Essential Functions/Responsibilities The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout its lifecycle. This includes generating all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. • Provide Medical Safety/PV inputs to the assigned products at Jazz Pharmaceuticals, which may include Clinical Development program of all phases, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence • Provide Medical safety/PV inputs to Jazz Pharmaceuticals Commercial organization to support global launch activities for assigned products • Participate in the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts, journal articles and other documents as needed, ensuring safety profile reflected for assigned products • Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and with the Jazz Labeling Committee ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling • Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products, as needed • Conduct signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders • Chair the Safety Management Team (SMT) of products under authority and participate in other executive forums for assigned products • Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products • Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements • Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; active involvement in inspection readiness activities, internal audits and external inspections • Represent PV in cross-functional forums and committees involving products under responsibility to achieve the Company's goals • Contribute to key performance indicators to ensure PV excellence • Maintain knowledge of Jazz Pharmaceuticals indications for investigational and/or marketed products assigned • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities 2 Required Knowledge, Skills, and Abilities • Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas and European Union, territories including an understanding of case processing procedures and other pharmacovigilance processes • Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems • MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries • Working experience with PV audit process with active participation in Regulatory Authority Inspections is preferred • Ability to manage multiple tasks with deadlines in fast-paced working environment • Knowledge of drug development process • Requires a high level of initiative and independence • Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork • Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word • Some national/international travel may be required 3 Required/Preferred Education and Licenses • MD required (or equivalent); medical licensure in at least one state preferred; clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus • Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience. Other relevant experience may be considered Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $212,000.00 - $318,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • Carlsbad, CA

  • no content

Medical Director, Medical Safety

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with PV management to ensure the safety assessment of priority product/s, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. Essential Functions Job Responsibilities and Requirements: Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s. Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team. Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective. Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling. Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed. Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Participate in or Lead a Safety Management Team (SMT) for an assigned product. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s. Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements. Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data. Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards. Provide safety expertise to due diligence activities, if/ as needed. Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities. Required Knowledge, Skills, and Abilities Minimum Requirements Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered. Excellent knowledge of drug development process. Requires a high level of initiative and independence. Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork. Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word. Some national/international travel may be required. Leadership Skills Enterprise and Proactive Mindset-demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment. Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change. Inspire & Mobilize Others: Serve as a positive role model - create followership and effectively mobilize and influence others, both on your teams and across the organization. Understanding of target product profile; clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP). Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred. Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus. MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus. Ability to manage multiple tasks with deadlines in fast-pace environment. Required/Preferred Education and Licenses MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $256,000.00 - $384,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

  • East Palo Alto, CA

  • no content