Associate Medical Director US Medical Affairs -Gastroenterology

Role Summary

Associate Medical Director US Medical Affairs -Gastroenterology based in Horsham, PA. Join the US Medical Affairs Immunology team to influence product development, scientific communication, and evidence generation efforts, ensuring alignment with business objectives and regulatory standards.

Responsibilities

• Serve as the Study Responsible Physician (SRP) for one or more studies, responsible for the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the Gastroenterology TA, with mentorship and supervision. This includes study design, protocol development, regulatory communications, academic and community-based IBD HCP and investigator interactions, support of execution, and supervision of clinical studies of all types, including Phase IIIb/IV, registries, real world evidence, and investigator-initiated studies and collaborations supported by US Medical Affairs within the TA.
• Contributes to US GI Medical Affairs strategy, working cross-functionally with partners within the GI Integrated evidence team (IET), RWV&E, IET Leads, SCG, Marketing brand teams, and potentially IBD DAS, R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the GI TA Strategy for establishing access as well as evidence generation and dissemination.
• Contributes to the preparation of regulatory submissions and interactions with Health Authorities (and particularly the US FDA) and helps to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods.
• Contributes as a subject matter expert on data in support of US Immunology approved (or planned) GI drugs and indications, partnering with respective marketing brand teams (as well as other commercial and IET partners, including RWVE, SCG, V&E Field and Med Info and other CAC partners).
• Partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (e.g., Biostats, GCO, Regulatory Affairs, QA and QC) to create Analysis Plans, safety data review for database locks and ensure compliance with SOP/GCP requirements (and support audits, as needed).
• Contributes to or leads the development of abstracts and manuscripts related to J&J supported and sponsored studies, focusing on IBD-related efficacy, outcomes, and safety/adverse event analyses.
• Builds and manages effective relationships with key opinion leaders and investigators related to Medical Affairs studies and strategic initiatives.

Qualifications

• MD/DO degree (or international equivalent) required. Board Certification/Eligibility in Gastroenterology or Immunology preferred
• Pharmaceutical industry interaction and/or post-graduate clinical medical practice with experience in clinical immunology/gastroenterology and/or experience with clinical studies, registries, epidemiology or health outcomes required
• Experience in gastroenterology, particularly in inflammatory bowel disease highly preferred
• Experience with 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, including effective oral presentations
• Strong time management skills and accountability for deliverables and timelines
• Ability to work in a matrix environment and lead cross-functional teams
• Energy, leadership potential, and willingness to build new expertise
• Approximately 10% to 20% annual travel required (primarily domestic, occasionally international)
• Location: Horsham, PA with hybrid schedule (three days in office, two remote)

Skills

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

Education

• MD/DO degree (or international equivalent)

Additional Requirements

• Hybrid work location: Horsham, PA with three days in the office and two days remote