Johnson & Johnson Careers
Director, Clinical Scientist, Medical Affairs, GI, Immunology
Requisition ID: 2501180527
Janssen Scientific Affairs, L.L.C., a Johnson and Johnson Company, is recruiting for a Director, Clinical Scientist, Medical Affairs- GI, Immunology to be based in Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Scientific Affairs, L.L.C. is dedicated to providing medical information and consultative support to the Janssen pharmaceutical companies. To learn more about our immunology products please visit: https://www.janssenbiotech.com/products/immunology
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Director, Clinical Scientist resides in the Gastroenterology Therapeutic Area Strategy (TAS) Team which is responsible for developing, coordinating and executing the Therapeutic Area strategic plan for Medical Affairs as well as executing supportive safety and efficacy studies, including those that are a result of US regulatory post-marketing commitments. This therapeutic area strategic plan seeks to identifying and addressing key stakeholders’ knowledge gaps through data dissemination, data generation and education. The position is primarily responsible for designing and executing registries, Phase IIIb/IV trials and other post-marketing requirements within current or emerging US GI indications.
- Responsible for the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the Gastroenterology TA. This will include study design, protocol development, regulatory communications, KOL and investigator interactions, support of execution, and supervision (as a SRS) of clinical studies of all types: Phase IIIb/IV, registries, real world evidence, and investigator initiated studies supported by Medical Affairs
- Work cross-functionally with other TAs, IBD Disease Area Stronghold (DAS), R&D, HECOR, IETLs, Global Medical Affairs and Commercial to promote and execute the GI TA Strategy, with focus on safety data
- Actively contribute as an expert on previous and new data on approved immunology products, and provide advice and input to the IET, Commercial, HECOR and Medical Information Teams
- Contribute to or lead the development of abstracts and manuscripts related to Janssen supported and sponsored studies, with a focus on safety analyses and experience
- Support and partner with individuals in GI and other groups inside and outside Medical Affairs (e.g. Other MA TAs, Biostats, Global Clinical Operations, Regulatory Affairs, QA and QC) to support Analysis Plans, safety data review for database locks and ensure compliance with study monitoring and other SOP/GCP requirements (and support audits, as needed).
- A minimum of Bachelor’s degree is required.
- An advanced degree (i.e. Master’s, Phd, PharmD, etc) is preferred.
- A minimum of 8-10 years of industry clinical and managerial experience in pharmaceutical trial design and study execution/conduct (Phases II-IV) is required
- Experience in having responsibility for safety data review or monitoring and/or pharmacovigilance experience within the pharmaceutical industry, CRO or academia is highly desirable.
- Previous leadership experience in overseeing clinical research is required
- Immunology therapeutic area experience is preferred
- Experience developing strategy as well as business goals and objectives across a portfolio is preferred
- Ability to operate in a matrix environment and experience working with cross-functional alliances is required
- This position will be located in Horsham, PA and will require up to 10% domestic and international travel.
Janssen Scientific Affairs, LLC (6120)