Medical Director, Gastroenterology Therapeutic Area, US Medical Affairs

Johnson & Johnson Innovative Medicine•Horsham, PA

3d•Hybrid

About The Position

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. They will work closely with the other Gastroenterology Medical Directors (and Associate Directors) as well as partners in US and Global Medical Affairs, Real World Value and Evidence (RWV&E), Population Health, Epidemiology, R&D, Biostatistics, and US and Global Commercial Team members supporting Immunology and Gastroenterology within the Johnson & Johnson Innovative Medicine organization to create, shape, influence, and drive strategy for GI pipeline and approved products including evidence generation plans and subsequent execution, ensuring alignment with business objectives and regulatory standards. They will also lead and/or contribute to the development of related abstracts and manuscripts as either an author or reviewer. The Medical Director, Gastroenterology will also be responsible for leading the strategic development and execution of US Medical Affairs-sponsored and supported clinical studies (e.g. Phase IIIb/IV trials, Post-Marketing Requirement studies, and investigator-initiated and collaborative studies) for company products in the Gastroenterology TA. Also, partnering with other GI team members in the US and Global Medical Affairs Organization, as well as Real World Value and Evidence (RWV&E), Epidemiology, R&D, biostatistics, commercial Marketing brand, and field based (e.g. MSL, commercial, and payer-facing value and evidence) teams they will shape the clinical and economic value narrative for one or more GI products/indications by participating in and/or leading their Integrated Evidence Team (IET), accountable for a strong scientific strategy and its execution through evidence generation efforts and their subsequent impactful presentation and dissemination approaches. If you are a strategic thinker with a passion to advance clinical science aspiring to improve the lives of patients with IBD, this is your opportunity to make a difference!

Requirements

An MD/DO degree (or international equivalent) is required.
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.
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.

Nice To Haves

Current or prior Board Certification (or Eligibility) in Gastroenterology and/or experience in R&D (or otherwise designing and conducting clinical trials) is preferred.
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.
People leadership is an asset.

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.