Associate Medical Director, Gastroenterology TA - US Medical Affairs

Associate Medical Director, Gastroenterology (US Medical Affairs) — Horsham, PA (Hybrid)

Key Responsibilities
- Serve as the Study Responsible Physician/scientist (SRP/SRS) for one or more studies; develop and execute Medical Affairs sponsored/supported clinical programs (including study design, protocol development, regulatory communications, investigator/IHCP interactions, execution support, and supervision across Phase IIIb/IV, registries, real-world evidence, investigator-initiated studies, and collaborations).
- Partner with Gastroenterology TA and other Medical Affairs groups (e.g., Biostats, GCO, Regulatory Affairs, QA/QC) to create analysis plans, conduct safety data review for database locks, and ensure compliance with study monitoring and SOP/GCP requirements (and support audits as needed).
- Contribute to US GI Medical Affairs strategy and possibly lead integrated evidence teams (IETs) to execute GI TA strategy for market access.
- Contribute to regulatory submissions and interactions with Health Authorities (including US FDA); help ensure post-marketing commitments are met with cost-effective, efficient, scientifically rigorous methods.
- Contribute to, and possibly lead, an Integrated Evidence Generation Plan (IEGP) and support payer-related materials/data to support market access.
- Become a subject matter expert on new and prior data for US Immunology-approved/planned GI drugs/indications (including IBD) and partner with marketing and IET/commercial partners.
- Review and evaluate investigator-initiated study (IIS) concepts; champion prioritized concepts through review, approval, funding, and monitor progress/milestones.
- Support fulfillment of medical information requests; develop medical education content with medical communications and scientific exchange teams.
- Contribute to abstracts and manuscripts (focus on IBD efficacy, outcomes, safety/adverse event analyses).
- Develop relationships with key opinion leaders and investigators.

Qualifications / Requirements
- MD/DO (or international equivalent); current or prior Board Certification or Eligibility in Gastroenterology strongly preferred.
- At least 2 years pharmaceutical industry experience and/or at least 5 years post-graduate clinical practice including clinical gastroenterology and/or clinical studies, registries, epidemiology, or health outcomes experience.
- Strong analytical/strategic thinking; scientific writing; strong organizational, written, verbal communication; effective scientific oral presentations.
- Strong organizational and time management; accountability for deliverables and timelines.
- Ability to work in a matrix environment and participate/lead cross-functional teams.
- Leadership potential, energy/enthusiasm, and ability/desire to build new expertise.
- Proficiency in English.
- 10%–20% annual travel (primarily domestic, occasionally international).

Required/Preferred Skills
- Required: Immunology; Pharmaceutical Medical Affairs
- Preferred: Communication; Medical Affairs; Medical Communications; Strategic Thinking

Base Pay Range
- $159,000.00 - $274,850.00