Medical Director, Gastroenterology Therapeutic Area, US Medical Affairs

Job Function: Medical Affairs Group

Job Sub Function: Medical Affairs – MD

Job Category: Scientific/Technology

All Job Posting Locations: Horsham, Pennsylvania, United States of America

Job Description

We are searching for outstanding talent for Medical Director, Gastroenterology, US Medical Affairs to join the Gastroenterology TA team within the US Immunology Medical Affairs organization located in Horsham, PA. This role will be a key member of the Medical Affairs Gastroenterology Therapeutic Area (TA) Team and will report to the Senior Director, Gastroenterology TA Lead within the broader US Medical Affairs- Immunology organization.

Responsibilities

• Develop and execute (as Study Responsible Physician [SRP]) Medical Affairs sponsored clinical study programs, including but not limited to Phase 3b/4 trials, registries, real-world evidence studies, investigator-initiated and/or collaborative studies in the Gastroenterology TA.
• Contribute to and/or lead study design, protocol development, clinical study report and publication development.
• Work closely with the matrix clinical trial teams and external investigators/KOLs on study operations and provide program leadership and medical oversight.
• Contribute to US GI Medical Affairs strategy, e.g. by leading one or more approved and pipeline GI products/indications Integrated Evidence Teams (IETs), working cross-functionally with partners within the GI Integrated evidence team (IET), including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing team brand leads, as well as potentially IBD Disease Area Stronghold (DAS), R&D, Global Medical Affairs and Global Commercial partners to promote and execute the GI TA Strategy for establishing access as well as plans for and progress and outcomes for evidence generation activities and Data Dissemination Plans.
• Contribute to the preparation of regulatory submissions and interactions with Health Authorities (and particularly the FDA) and helps to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods.
• Will contribute to, and potentially lead (as the Integrated Evidence Team Lead [IETL]), the cross-functional team to develop and maintain a strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline GI products/indications.
• Also will support payer-related materials and evidence needs to scientifically support market access efforts.
• Reviews and evaluates Investigator-Initiated Study (IIS) concepts, champion prioritized concepts through appropriate review, approval, & funding, and monitor study progress/milestones.
• Contributes as a subject matter expert on previous and new data in support of US Immunology approved (or planned) GI drugs and indications, partnering particularly 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).
• Actively partners with individuals in the Gastroenterology TA, and other groups inside and outside Medical Affairs (e.g. Biostats, GCO, Regulatory Affairs, QA and QC), to create analysis plans, perform safety data review for database locks, and ensure compliance with study monitoring and other SOP/GCP requirements (and support related audits, as needed).
• Support the fulfillment of medical information requests from field medical and field commercial teams.
• Support/lead the development of medical education content for field medical team.
• Partner with medical communications and scientific exchange teams on content development, review, and approval.
• Contributes to or leads the development of abstracts and manuscripts related to Innovative Medicine supported and sponsored studies, including cumulative and/or directed safety experience.
• Develop strong relationships with IBD key opinion leaders (KOLs), collaborating with new and established leaders in the field of IBD through clinical trial development and various medical affairs activities.
• Establish and foster relations with medical societies and patient advocacy organizations.
• Travel: Up to 20% domestic and limited international.
• Hybrid schedule: 3 days in office and up to 2 remote days per week.

Qualifications & Requirements

• An MD/DO degree (or international equivalent) is required.
• Current or prior Board Certification (or Eligibility) in Gastroenterology and/or experience in R&D (or otherwise designing and conducting clinical trials) is preferred.
• A minimum of 8 years of combined industry, academic, clinical research, or other clinical practice experience is required, of which at least 3 years in the pharmaceutical industry, including accountability for successful and timely execution of key deliverables.
• Gastroenterology and/or Immunology Therapeutic Area expertise is preferred.
• Prior industry/medical affairs experience, including commercial brand support, medical launch support experience, and clinical study, registry, or real-word evidence study support and execution is preferred.
• Prior R&D (or other) experience including responsibility and accountability for clinical study planning and execution is a strong asset.
• Excellent analytical and strategic thinking aptitude, scientific writing proficiency, and strong organizational, written, and verbal communication skills, including proficiency in effective and impactful scientific oral presentations is essential.
• Strong leadership, teaming, and collaboration skills and the ability to work in a matrix environment, collaborating effectively with many cross functional partners and success in participating in and leading cross functional teams to execute on deliverables is essential.
• People leadership is an asset.
• Up to 20% travel (primarily domestic & limited international) is required.
• This position is located in Horsham, PA and follows a hybrid schedule of three days in the office and up to two days remote per week.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.