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.
\nThis 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.
\nAt 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.
\nThis 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.
\nReporting 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.
\nAccountabilities:
\nUS 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.
\nProvide strategic medical input to US brand and launch strategy, ensuring alignment of scientific priorities with patient and clinical needs.
\nTranslate complex biology, clinical data, and disease state-insights into actionable US medical strategies.
\nPre-Approval Medical Affairs Responsibilities - Lead US medical strategy for late-stage clinical development, including:
\nUS input into Phase 3/3b study design
\nEndpoint relevance to US clinical practice
\nSubpopulation and biomarker strategy
\nSupport US regulatory readiness through medical review, scientific positioning, and collaboration with regulatory and global partners.
\nDevelop and implement pre-approval external scientific engagement strategy consistent with regulations, including:
\nScientific exchange on disease biology and unmet need
\nAdvisory boards focused on clinical trial interpretation and future treatment paradigms
\nContribute to launch readiness planning, including:
\nMedical education strategy
\nScientific platform development
\nMedical training for Field Medical teams
\nPartner with evidence, payer, and outcomes teams to define early value evidence strategy relevant to the US healthcare environment.
\nPost-Approval Medical Affairs Responsibilities - Lead ongoing post-approval medical strategy to support appropriate scientific exchange and optimize patient care.
\nLead all aspects of Phase 4 and lifecycle management strategy, including real-world-evidence (RWE) and effectiveness studies relevant to US clinicians and payers.
\nProvide medical leadership for:
\nUS publication strategy and congress planning
\nMedical review of promotional and non-promotional materials
\nScientific response strategy and data dissemination
\nServe as a medical spokesperson for the US brand as appropriate, supporting external scientific discussions and media inquiries.
\nMaintain accountability for the evolving US product scientific narrative, incorporating new data, guidelines, and real-world insights.
\nExternal Engagement & Scientific Exchange (US Focused) - Design and implement a comprehensive US external engagement plan, including:
\nKey Opinion Leaders (KOLs)
\nAcademic institutions
\nIntegrated delivery networks and hospital systems
\nProfessional societies
\nLead planning and participation in national and regional US medical advisory boards.
\nEnsure high-quality, compliant scientific exchange that advances understanding of COPD pathophysiology.
\nEvidence Generation & Medical Governance - Collaborate with medical evidence and payer teams to design and implement:
\nClinical effectiveness studies
\nRWE and health outcomes research
\nProvide medical review and governance for Externally Sponsored Research (ESR) proposals.
\nProvide medical input into product safety strategy in collaboration with Patient Safety colleagues.
\nEnsure compliance with all US regulatory requirements, OPDP standards, PhRMA Code, and AstraZeneca policies.
\nInternal Collaboration & Capability Building - Provide clinical education and scientific training for:
\nUS Field Medical organization
\nCross-functional-partners (commercial, market access, HEOR)
\nAct as a trusted US medical advisor to internal team members on COPD disease strategy and emerging science.
\nMaintain strong collaboration with global medical and clinical teams, ensuring seamless alignment while representing US medical needs.
\nMinimum Requirements - Doctoral degree (MD, PhD, MBBS or PharmD) or equivalent education
\n3+ years of demonstrated experience or strong expertise in Pulmonary Medicine, respiratory pharmacology, or immune-mediated-disease.
\nExperience in late-phase clinical development and/or post-approval medical affairs.
\nWell-developed comprehension of the US regulatory environment, including FDA and OPDP.
\nExcellent scientific communication, presentation, and customer engagement skills.
\nAbility to travel 20-25% on average within the US and occasionally internationally.
\nPreferred Requirements - Board certification or eligibility in Pulmonary or Internal Medicine.
\nStrong biologics and new product launch experience
\nPrior US pharmaceutical medical affairs experience, preferably in respiratory or biologics.
\nExperience supporting first-in-class, disease-modifying, or specialty launches.
\nStrong understanding of the US payer and provider landscape.
\nDemonstrated success in cross-functional-leadership and launch execution.
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