Medical Director, Gastroenterology Therapeutic Area, US Medical Affairs
Johnson & Johnson
June 26, 2026
Remote friendly (Horsham, PA)
United States
Medical Affairs
Medical Director, Gastroenterology, US Medical Affairs (Horsham, PA)
Purpose
- Lead strategy and execution for GI pipeline and approved products, including evidence generation plans and execution, aligned to business 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 and supported clinical studies for GI Therapeutic Area products.
You will be responsible for
- Develop and execute Medical Affairs sponsored clinical study programs (e.g., Phase 3b/4, registries, real-world evidence, investigator-initiated/collaborative studies) as Study Responsible Physician (SRP).
- Contribute to/lead study design, protocol development, clinical study reports, and publication development; oversee study operations and provide medical oversight.
- Contribute to GI Medical Affairs strategy via Integrated Evidence Teams (IETs) and develop/maintain Integrated Evidence Generation Plan (IEGP); support payer evidence for market access.
- Review/evaluate Investigator-Initiated Study (IIS) concepts; monitor progress/milestones.
- Perform safety data review for database locks; ensure compliance with SOP/GCP and support audits as needed.
- Support medical information requests; develop medical education content; partner on medical communications/scientific exchange.
- Develop relationships with IBD KOLs; collaborate with societies and patient advocacy organizations.
Qualifications/Requirements
- MD/DO required. Board certification/eligibility in Gastroenterology and/or clinical trials experience preferred.
- 8+ years combined industry/academic/clinical research/clinical practice; 3+ years in pharma with accountability for key deliverables.
- Gastroenterology and/or Immunology TA expertise preferred.
- Strong leadership and collaboration in matrix environments.
- Up to 20% travel; hybrid schedule (3 days office, up to 2 days remote).
Required/Preferred Skills
- Clinical Research, Gastroenterology, Immunology, Medical Affairs, Research and Development, Strategic Thinking; analytical/strategic thinking, scientific writing, strong communication and presentation skills.
Purpose
- Lead strategy and execution for GI pipeline and approved products, including evidence generation plans and execution, aligned to business 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 and supported clinical studies for GI Therapeutic Area products.
You will be responsible for
- Develop and execute Medical Affairs sponsored clinical study programs (e.g., Phase 3b/4, registries, real-world evidence, investigator-initiated/collaborative studies) as Study Responsible Physician (SRP).
- Contribute to/lead study design, protocol development, clinical study reports, and publication development; oversee study operations and provide medical oversight.
- Contribute to GI Medical Affairs strategy via Integrated Evidence Teams (IETs) and develop/maintain Integrated Evidence Generation Plan (IEGP); support payer evidence for market access.
- Review/evaluate Investigator-Initiated Study (IIS) concepts; monitor progress/milestones.
- Perform safety data review for database locks; ensure compliance with SOP/GCP and support audits as needed.
- Support medical information requests; develop medical education content; partner on medical communications/scientific exchange.
- Develop relationships with IBD KOLs; collaborate with societies and patient advocacy organizations.
Qualifications/Requirements
- MD/DO required. Board certification/eligibility in Gastroenterology and/or clinical trials experience preferred.
- 8+ years combined industry/academic/clinical research/clinical practice; 3+ years in pharma with accountability for key deliverables.
- Gastroenterology and/or Immunology TA expertise preferred.
- Strong leadership and collaboration in matrix environments.
- Up to 20% travel; hybrid schedule (3 days office, up to 2 days remote).
Required/Preferred Skills
- Clinical Research, Gastroenterology, Immunology, Medical Affairs, Research and Development, Strategic Thinking; analytical/strategic thinking, scientific writing, strong communication and presentation skills.