US Medical Director COPD Biologics

Introduction to role:

TheUS Medical Affairs Director COPD Biologicsprovides 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 aphysician or pharmacistwith deep expertise in pulmonary medicine and experience acrosslate-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 theUS medical leadfor COPD Biologics accountable for development and execution of theUS Brand Medical Planacross 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.

PreApproval Medical Affairs Responsibilities

• Lead US medical strategy forlate stage clinical development including:
  • US input into Phase 3/3b study design
  • Endpoint relevance to US clinical practice
  • Subpopulation and biomarker strategy

• SupportUS regulatory readinessthrough medical review scientific positioning and collaboration with regulatory and global partners.

• Develop and implementpreapproval external scientific engagementstrategy consistent with regulations including:
  • Scientific exchange on disease biology and unmet need
  • Advisory boards focused on clinical trial interpretation and future treatment paradigms

• Contribute tolaunch readiness planning including:
  • Medical education strategy
  • Scientific platform development
  • Medical training for Field Medical teams

• Partner with evidence payer and outcomes teams to defineearly value evidence strategyrelevant to the US healthcare environment.

Post Approval Medical Affairs Responsibilities

• Lead ongoingpostapproval medical strategyto support appropriate scientific exchange and optimize patient care.
• Lead all aspects ofPhase 4 and lifecycle managementstrategy 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 nonpromotional materials
  • Scientific response strategy and data dissemination
• Serve as amedical spokespersonfor the US brand as appropriate supporting external scientific discussions and media inquiries.
• Maintain accountability for the evolvingUS product scientific narrative incorporating new data guidelines and real-world insights.

External Engagement & Scientific Exchange (US Focused)

• Design and implement a comprehensiveUS 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 regionalUS 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 forExternally Sponsored Research (ESR)proposals.
• Provide medical input intoproduct safety strategyin collaboration with Patient Safety colleagues.
• Ensure compliance with allUS 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 withglobal 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 inPulmonary 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 inPulmonary or Internal Medicine.
• Strong biologics and new product launch experience
• PriorUS pharmaceutical medical affairs experience preferably in respiratory or biologics.
• Experience supportingfirst in class disease modifying or specialty launches.
• Strong understanding of theUS 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 $200693 $275000 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 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 -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca we are driven by our commitment to deliver accelerated growth for AstraZeneca and make peoples lives better. We thrive in our often-intense environment by seeking out new challenges and working towards innovative solutions. Here you can build a long-term career with global knowledge opportunities while positively impacting local communities.

Ready to step up Apply now to join our team!

Date Posted

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.