Associate Medical Director US Medical Affairs -Gastroenterology

Role Summary

The Associate Medical Director, US Medical Affairs - Gastroenterology is a key member of the US Medical Affairs Immunology team, influencing product development, scientific communication, and evidence generation efforts to align with business objectives and regulatory standards. This role supports the Gastroenterology Therapeutic Area by developing and executing medical affairs-sponsored programs, collaborating with cross-functional partners, and contributing to abstracts and manuscripts related to IBD–focused data. The position reports to the Head, Gastroenterology US Medical Affairs- Immunology and is based in Horsham, PA with a hybrid work schedule.

You Will Be Responsible For

• Serve as the Study Responsible Physician (SRP) for one or more studies, developing and executing Medical Affairs sponsored and supported clinical programs in Gastroenterology TA, including study design, protocol development, regulatory communications, HCP and investigator interactions, and supervision of diverse study types (Phase IIIb/IV, registries, real world evidence, investigator-initiated studies).
• Contribute to US GI Medical Affairs strategy, collaborating with the GI Integrated Evidence Team and cross-functional partners to promote access, evidence generation, and dissemination.
• Assist in regulatory submissions and interactions with Health Authorities (notably US FDA), ensuring post-marketing commitments are met efficiently with rigorous methods.
• Act as a subject matter expert on data supporting GI drugs and indications, partnering with marketing teams and other IET/Commercial partners.
• Collaborate with Gastroenterology TA and other groups (Biostats, GCO, Regulatory Affairs, QA/QC) to create Analysis Plans, safety data reviews, and ensure SOP/GCP compliance; support audits as needed.
• Contribute to or lead development of abstracts and manuscripts for sponsored studies, focusing on IBD-related efficacy, outcomes, and safety analyses.
• Build and manage relationships with key opinion leaders and investigators related to Medical Affairs studies and initiatives.

Qualifications

• MD/DO degree (or international equivalent) required; Board Certification or Eligibility in Gastroenterology or Immunology preferred.
• Pharmaceutical industry experience and/or post-graduate clinical practice with experience in clinical immunology/gastroenterology and/or clinical studies, registries, epidemiology, or health outcomes required.
• Experience in gastroenterology, particularly inflammatory bowel disease, highly preferred.
• Experience with planning and execution/writing of regulatory submissions, protocols, and/or scientific manuscripts preferred.
• Experience with data analysis and review, and/or clinical study execution as investigator or medical monitor/clinical scientist preferred.
• Experience with immunologic biologics and small molecules preferred.
• Strong organizational, written, and verbal communication skills; ability to deliver effective oral presentations required.
• Strong time management and accountability for deliverables and timelines.
• Ability to work in a matrix environment and lead cross-functional teams.
• Energy, leadership potential, and adaptability to build new expertise are essential.
• Approximately 10% to 20% annual travel required (domestic; occasional international).
• Location: Horsham, PA with a hybrid schedule (three days in office, two remote per week).

Skills

• Analytical Reasoning
• Clinical Research and Regulations
• Clinical Trials Operations
• Communication
• Healthcare Trends
• Medical Affairs
• Medical Communications
• Medical Compliance
• Productivity Planning
• Product Strategies
• Publications Management
• Scientific Research
• Strategic Thinking
• Tactical Planning
• Team Management
• Technical Credibility

Additional Requirements

• Travel: Approximately 10% to 20% annual travel (primarily domestic, occasionally international).
• Location: Horsham, PA; hybrid schedule (three days in office, two days remote).