US Medical Director - COPD Biologics (Town of Florida)
Relevant skills and experience will be listed so you know why those jobs are a match Job Description Introduction to role: The US Medical Affairs Director – COPD Biologics provides US focused‐ medical leadership for all phases of Chronic Obstructive Pulmonary Disease (COPD). The role is an integral part of the US Core Medical Team (CMT). It serves as the primary US medical point of accountability for scientific strategy, evidence generation, and external engagement.This role is ideally suited for a physician or pharmacist with deep expertise in pulmonary medicine and experience across late-stage development, launch readiness, and post approval‐ medical excellence. The Medical Director ensures US medical strategy is aligned with global direction while remaining responsive to the healthcare and clinical landscape within the United States.At AstraZeneca, teams work across global boundaries to make an impact and find answers to complex challenges. This role sits at the heart of that mission, combining scientific depth with strategic leadership to advance care in chronic respiratory disease. This position completes the medical strategy and carries out the execution for a novel Interleukin-33 targeting monoclonal antibody, crafting both product and disease area direction across the full lifecycle.Reporting directly to the US Medical Head, COPD Biologics, this leader will guide a high-performing team, drive launches, and influence how evidence, access and clinical practice come together to transform outcomes for patients living with COPD and severe lower respiratory tract disease. Accountabilities US Medical Strategy & Asset Leadership * Serve as the US medical lead for COPD Biologics, accountable for development and execution of the US Brand Medical Plan across pre and post approval‐ stages.* Provide strategic medical input to US brand and launch strategy, ensuring alignment of scientific priorities with patient and clinical needs.* Translate complex biology, clinical data, and disease state‐ insights into actionable US medical strategies. Pre‐Approval Medical Affairs Responsibilities * Lead US medical strategy for late stage‐ clinical development , including: US input into Phase 3/3b study design Endpoint relevance to US clinical practice Subpopulation and biomarker strategy* Support US regulatory readiness through medical review, scientific positioning, and collaboration with regulatory and global partners.* Develop and implement pre‐approval external scientific engagement strategy consistent with regulations, including: Scientific exchange on disease biology and unmet need Advisory boards focused on clinical trial interpretation and future treatment paradigms* Contribute to launch readiness planning , including: Medical education strategy Scientific platform development Medical training for Field Medical teams* Partner with evidence, payer, and outcomes teams to define early value evidence strategy relevant to the US healthcare environment. Post Approval‐ Medical Affairs Responsibilities * Lead ongoing post‐approval medical strategy to support appropriate scientific exchange and optimize patient care.* Lead all aspects of Phase 4 and lifecycle management strategy, including real-world‐ evidence (RWE) and effectiveness studies relevant to US clinicians and payers.* Provide medical leadership for: US publication strategy and congress planning Medical review of promotional and non‐promotional materials Scientific response strategy and data dissemination* Serve as a medical spokesperson for the US brand as appropriate, supporting external scientific discussions and media inquiries.* Maintain accountability for the evolving US product scientific narrative , incorporating new data, guidelines, and real-world insights. External Engagement & Scientific Exchange (US Focused) * Design and implement a comprehensive US external engagement plan , including: Key Opinion Leaders (KOLs) Academic institutions Integrated delivery networks and hospital systems Professional societies* Lead planning and participation in national and regional US medical advisory boards .* Ensure high-quality, compliant scientific exchange that advances understanding of COPD pathophysiology. Evidence Generation & Medical Governance * Collaborate with medical evidence and payer teams to design and implement: Clinical effectiveness studies RWE and health outcomes research* Provide medical review and governance for Externally Sponsored Research (ESR) proposals.* Provide medical input into product safety strategy in collaboration with Patient Safety colleagues.* Ensure compliance with all US regulatory requirements , OPDP standards, PhRMA Code, and AstraZeneca policies. Internal Collaboration & Capability Building * Provide clinical education and scientific training for: US Field Medical organization Cross functional‐ partners (commercial, market access, HEOR)* Act as a trusted US medical advisor to internal team members on COPD disease strategy and emerging science.* Maintain strong collaboration with global medical and clinical teams , ensuring seamless alignment while representing US medical needs. Minimum Requirements * Doctoral degree (MD, PhD, MBBS or PharmD) or equivalent education* 3 years of demonstrated experience or strong expertise in Pulmonary Medicine , respiratory pharmacology, or immune mediated‐ disease.* Experience in late-phase clinical development and/or post-approval medical affairs.* Well-developed comprehension of the US regulatory environment, including FDA and OPDP.* Excellent scientific communication, presentation, and customer engagement skills.* Ability to travel 20-25% on average within the US and occasionally internationally. Preferred Requirements * Board certification or eligibility in Pulmonary or Internal Medicine .* Strong biologics and new product launch experience* Prior US pharmaceutical medical affairs experience, preferably in respiratory or biologics.* Experience supporting first in class, disease modifying, or specialty launches.* Strong understanding of the US payer and provider landscape.* Demonstrated success in cross functional‐ leadership and launch execution. Pay Transparency The annual base pay for this position could range from $200,693 – $275,000 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employees will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's
