Director Medical Affairs GI

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•$164,000 - $282,900•Hybrid

About The Position

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Immunology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Medical Director, Gastroenterology Therapeutic Area – US Medical Affairs based in Horsham, PA. Purpose : 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 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 (Eg. 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 (Eg 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.

Requirements

An advanced degree (MD/DO, PhD, PharmD, DNP, etc.) is required.
A minimum of 8 years of combined relevant experience in academic clinical research, clinical practice, and/or pharmaceutical industry with include a history of accountability for key deliverables with demonstration of their timely and successful execution is required.
Gastroenterology or Immunology Therapeutic Area expertise is strongly preferred.
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 succeed in participating in and leading cross functional teams to execute on deliverables is essential.
Proficiency in English is necessary.
Up to 20% travel (primarily domestic & limited international) is required.

Nice To Haves

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 experience with responsibility and accountability for clinical study planning and execution is also a strong asset.

Responsibilities

Develop and execute (as Study Responsible Physician or Scientist [SRP/SRS]) 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/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, Eg 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.
Contributes to, and potentially leads (as the IETL), the cross-functional team to develop and maintain a current, strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline GI products/indications. And supports payer-related materials and data 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 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, including cumulative and/or directed safety 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.