Medical Director, Gastroenterology Therapeutic Area - Medical Affairs

Johnson and Johnson is recruiting for a Medical Director, Gastroenterology within our US Immunology Medical Affairs organization located in Horsham, PA.

At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.

The Medical Affairs Therapeutic Area (TA) team is responsible for developing, coordinating and executing the US Gastroenterology TA strategic plan for Medical Affairs. The Medical Director, Gastroenterology position will be responsible for leading the strategic development and execution of Medical Affairs sponsored and supported clinical programs (Phase IIIb/IV trials, any post-marketing requirements, investigator-initiated trials) for company products in the gastroenterology therapeutic area. The Medical Director, Gastroenterology will partner with other GI team members in the US and Global Medical Affairs Organization, as well as health economic and outcomes research, Real World Value and Evidence (RWV&E), Epidemiology, R&D, biostatistics, commercial marketing and field (medical/ commercial/ value and evidence) based teams through integrated evidence teams (and other touchpoints) to formulate and execute scientific strategy on marketed and/or pipeline products, as well as supporting the fulfillment of medical information questions and issues that arise from the medical or commercial field teams and internal/external customers in the Gastroenterology TA.

Key Responsibilities:

• Develop and execute (as Study Responsible Physician [SRP]) Medical Affairs sponsored clinical 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/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, working cross-functionally with partners within the GI Integrated evidence team (IET), including RWV&E, IETLs, SCG, Marketing brand teams, 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 evidence generation and dissemination.
• 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.
• 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 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 study monitoring and other SOP/GCP requirements (and support 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 Janssen supported and sponsored studies, with a focus on safety analyses and experience.
• Identify new key opinion leaders (KOLs) and develop strong KOL collaborations on clinical trial development and medical affairs activities. Establish and foster relations with medical societies and patient advocacy organizations.