Medical Director, Gastroenterology Therapeutic Area, US Medical Affairs

Medical Director, Gastroenterology, US Medical Affairs — Purpose
- Key member of the Medical Affairs Gastroenterology Therapeutic Area (TA) Team; report to the Senior Director, Gastroenterology TA Lead.
- Create, shape, influence, and drive strategy for GI pipeline and approved products, including evidence generation plans and execution, aligned to business objectives and regulatory standards.
- Lead and/or contribute to development of abstracts and manuscripts.
- Lead strategic development and execution of US Medical Affairs-sponsored and supported clinical studies (e.g., Phase IIIb/IV, Post-Marketing Requirement, investigator-initiated and collaborative studies).
- Shape clinical and economic value narrative for one or more GI products/indications through Integrated Evidence Team (IET) participation/leadership.

You Will Be Responsible For
- Develop and execute Medical Affairs sponsored clinical study programs (SRP), including study design, protocol development, clinical study reports, and publications.
- Work with matrix clinical trial teams and external investigators/KOLs; provide program leadership and medical oversight.
- Contribute to GI Medical Affairs strategy via IETs; support access strategy, evidence generation progress/outcomes, and Data Dissemination Plans.
- Support regulatory submissions and FDA/Health Authority interactions; ensure post-marketing commitments are met with scientifically rigorous methods.
- Develop/maintain Integrated Evidence Generation Plan (IEGP) for approved/pipeline GI products/indications; support payer-related evidence needs.
- Review and evaluate IIS concepts; champion concepts through review/approval/funding and monitor milestones.
- Serve as subject matter expert on relevant data; support safety data review and ensure SOP/GCP compliance and audits as needed.
- Support medical information requests; support/lead medical education content for field medical teams.
- Develop abstracts/manuscripts; build relationships with IBD KOLs, medical societies, and patient advocacy organizations.

Qualifications / Requirements
- MD/DO required; preferred Board Certification/Eligibility in Gastroenterology and/or R&D experience designing/conducting clinical trials.
- Minimum 8 years combined industry/academic/clinical research/clinical practice; at least 3 years in pharma with accountability for timely key deliverables.
- Preferred: Gastroenterology and/or Immunology TA expertise; prior medical affairs/industry experience (brand, launch, study/registry/RWE execution); R&D experience with clinical study planning/execution.
- Essential: analytical/strategic thinking, scientific writing, strong organizational and communication skills; ability to lead in a matrix environment.
- Asset: people leadership.
- Up to 20% travel.

Preferred Skills
- Clinical Research, Gastroenterology, Immunology, Medical Affairs, Research and Development, Strategic Thinking