Study Responsible Physician

Study Responsible Physician (SRP) / Senior Responsible Scientist (SRS) Gastroenterology & Immunology | Contract Overview We are seeking a highly skilled, “dual-action” medical professional to serve as a SRP or SRS within the Gastroenterology team. This role is critical to supporting the continued growth of Tremfya following its recent approvals in Ulcerative Colitis (September 2024) and Crohn’s Disease (March 2025). The ideal candidate brings a rare combination of deep clinical trial leadership experience and a strategic Medical Affairs mindset, with the ability to operate effectively in a fast-paced, evolving environment. Key Responsibilities 1. Clinical Research & Medical Oversight • Lead and execute company-sponsored Phase 3b and Phase 4 clinical trials, including study design, execution, and lifecycle management • Serve as Medical Monitor for assigned studies, ensuring patient safety, data integrity, and protocol compliance • Oversee clinical and scientific integrity across all study activities • Manage regulatory submissions and ensure strict adherence to Good Clinical Practice (GCP) guidelines • Support and lead investigator meetings and clinical study-related engagements • Apply clinical expertise to interpret data trends and guide study direction 1. Strategic Data Dissemination & Scientific Communication • Lead multi-channel data dissemination strategy to support post-launch activities • Oversee development, review, and approval of: • Abstracts • Manuscripts/publications • Scientific posters • Drive execution of high-volume, high-quality scientific content generation • Lead Continuing Medical Education (CME) and digital medical education initiatives • Translate complex clinical data into clear, impactful scientific narratives 1. Cross-Functional Collaboration • Partner closely with: • Medical Science Liaisons (MSLs) • Commercial teams • Real World Value & Evidence (RWV&E) • Strategic Customer Group (SCG) • Support development of field-facing medical materials • Collaborate with commercial partners on promotional material development • Ensure alignment between clinical, medical, and commercial strategy 1. Regulatory, Legal & Compliance Leadership • Lead and participate in Medical, Legal, and Regulatory (MLR) / Copy Approval Committee (CAC) review processes • Ensure all external-facing materials meet medical, legal, and regulatory standards • Navigate internal governance processes to enable timely content approval and deployment 1. Strategic Insight & Medical Affairs Leadership • Apply clinical and endoscopic data interpretation in Gastroenterology to inform strategy • Utilize pattern recognition and data-driven insights to guide medical decision-making • Support post-launch medical strategy, including competitive positioning and lifecycle management • Operate effectively in a high-growth, high-demand (“hairy”) environment with evolving priorities Qualifications & Requirements Education • Senior Research Physician (SRP):MD, MBBS, or equivalent foreign medical degree required • Required for Medical Monitoring and clinical oversight responsibilities • Senior Research Scientist (SRS):PhD or PharmD • Focus on Medical Affairs strategy, scientific communication, and data dissemination Therapeutic Area Expertise (Preferred Hierarchy) 1. Gastroenterology (GI) – strongly preferred • Specific expertise in Ulcerative Colitis and Crohn’s Disease highly desirable • General Immunology/Rheumatology • Dermatology • Allergy/Immunology • Oncology - Acceptable if combined with strong Phase 3b/4 and Medical Monitoring experience Professional Experience • Proven track record leading Phase 3b and Phase 4 clinical trials • Experience serving as a Medical Monitor or equivalent clinical oversight role • Demonstrated success in: • Publication planning • Scientific content development • Promotional material review (MLR/CAC) • Strong experience in Medical Affairs activities and cross-functional collaboration • Ability to thrive in a fast-paced, collaborative, and evolving environment Reporting Structure • Reports to: • Medical Director, Gastroenterology OR Interim GI Therapeutic Area Lead Ideal Candidate Profile • Combines clinical trial execution expertise with Medical Affairs strategy experience • Comfortable operating across both clinical development and post-launch environments • Strong communicator with the ability to translate data into strategy and action • Adaptable and effective in environments with organizational change and rapid growth