Description
The US Medical 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) and 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.