Medical Director, Gastroenterology Therapeutic Area, US Medical Affairs

Purpose:
- Key member of the Medical Affairs Gastroenterology Therapeutic Area (TA) Team reporting to the Senior Director, Gastroenterology TA Lead; develop, shape, influence, and drive GI pipeline and approved product strategy, including evidence generation plans and execution aligned to business objectives and regulatory standards.
- Lead and/or contribute to development of abstracts and manuscripts as author or reviewer.
- Lead strategic development and execution of US Medical Affairs-sponsored/supported clinical studies (e.g., Phase IIIb/IV, Post-Marketing Requirement, investigator-initiated and collaborative studies).
- Partner cross-functionally (GI Medical Affairs, RWV&E, Epidemiology, R&D, biostatistics, commercial marketing/brand, and field teams) to shape clinical and economic value narratives via 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; provide program leadership and medical oversight with matrix teams and external investigators/KOLs.
- Contribute to/lead GI Medical Affairs strategy via IETs; support evidence generation and data dissemination.
- Support regulatory submissions and interactions (incl. FDA) and ensure post-marketing commitments are met with rigorous, cost-effective methods.
- Develop/maintain Integrated Evidence Generation Plan (IEGP); support payer-related evidence/market access materials.
- Review/evaluate IIS concepts; champion review/approval/funding; monitor progress/milestones.
- Serve as SME on data for GI drugs/indications; partner with marketing and IET partners.
- Create analysis plans, perform safety data review (database locks), ensure SOP/GCP compliance, and support audits.
- Support medical information requests; develop medical education content for field teams with medical communications.
- Contribute to/lead abstracts and manuscripts, including safety experience.
- Build relationships with IBD KOLs; engage medical societies and patient advocacy organizations.

Qualifications / Requirements:
- MD/DO required; preferred Board Certification/eligibility in Gastroenterology and/or clinical trials/R&D experience.
- Minimum 8 years combined industry/academic/clinical research/clinical practice; at least 3 years in pharmaceutical industry with accountability for timely delivery of key deliverables.
- Preferred: Gastroenterology and/or Immunology TA expertise; prior medical affairs/industry experience (brand, launch, clinical study/registry/RWE).
- Strong analytical/strategic thinking; scientific writing and strong written/verbal communication; effective scientific oral presentation skills.
- Essential: leadership, teamwork, collaboration in a matrix environment; people leadership is an asset.
- Required: up to 20% travel.
- Location/schedule: Horsham, PA; hybrid (3 days office, up to 2 days remote).

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