Associate Director, Medical Affairs - Gastroenterology Job

Company Name:
Janssen Scientific Affairs, LLC (6120)
Horsham, PA, US
Johnson & Johnson companies are equal opportunity employers.
Associate Director, Medical Affairs - Gastroenterology-9910140502
Janssen Biotech, Inc. is recruiting for an Associate Director of Gastroenterology, Medical Affairs, to be located in Horsham, PA.
For more than 30 years, Janssen Biotech, Inc. (JBI) has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Built upon a rich legacy of innovative first, Janssen Biotech, Inc. pursues innovative solutions in the therapeutic areas of immunology, oncology, urology and nephrology. With the same unwavering passion for new challenges, we dedicate ourselves to delivering solutions for these disease states where unmet needs continue to exist. Rooted in rich scientific collaborations and community-based relationships, we have access to some of the top minds in science today, allowing us to advance the treatment of patients through our innovative medicines. Our discoveries lead us not only to new treatments, but also to new ways to empower patients and expand their access to quality care.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Medical Affairs Therapeutic Area team is responsible for developing, coordinating and executing the Therapeutic Area strategic plan for Medical Affairs. This position resides in the GI Therapeutic Area Strategy (GI TAS) Team and is primarily responsible for designing and executing registries, Phase IIIb/IV trials and other post-marketing requirements within the areas of JBI's current or emerging indications. This position supports research in Immunology targeting gastroenterological conditions in late Phase III development. The GI TAS team includes Medical Affairs physicians, Research Scientists, and operations members. The Associate Director Clinical Research, Gastroenterology position will be part of the GI TAS team and will work closely with US and EU Medical Affairs team members on Gastroenterology research as well as with other key partners in JBI.
More specifically, the Associate Director will be responsible for the development and execution of Medical Affairs sponsored and supported clinical programs for company products in the Gastroenterology therapeutic area. This will include study design, protocol development, execution, and supervision of clinical studies of all types: Phase IIIb/IV, registries and investigator initiated studies supported by Medical Affairs. In addition, the Associate Director will manage people or groups within the GI TAS through a matrixed structure.
The successful applicant will be responsible for medical monitoring/reporting and company safety officer activities. Trial conduct and tracking will require close interaction with members of Global Clinical Operations directly responsible for each trial supported by the operating company. A strong working relationship with the Clinical Research and Development organization as well as Regulatory Affairs will be essential. The M.D./D.O. within GI TAS should be perceived as a peer by clinical research leaders in all disease areas under research as direct involvement in the interpretation and data display is anticipated. This applicant will also work with the strategic lead in Gastroenterology to support other appropriate efforts.
Essential Functions include: Direct involvement in trial design of Phase IIIb/IV research trials targeting gastroenterological diseases; Work closely with the clinical project scientist group and GCO to manage trial logistics; work closely with the project management representative(s) to track trial status; be prepared to quickly identify trial conduct and logistical problems and provide solutions to rectify the issues as appropriate; work closely with different US and European medical affairs teams, the GCO Clinical Project Liaisons, as well as other individuals within medical affairs and other functional areas within JNJ as necessary to facilitate research expanding the knowledge of all JBI marketed products; work with and communicate to the steering committees of trials; Write as well as provide editorial comments for phase IIIb/IV clinical study reports and manuscripts.
MD/DO required. Advanced training in Gastroenterology or experience conducting gastroenterology clinical trials is preferred. Drug development experience is an asset. Excellent written, oral and presentation skills are required. Strong organizational skills are a must. Demonstrated ability to work in a matrix environment with interaction with cross-functional teams is preferred. Up to 25% annual travel (domestic and international) is required for this position.
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Primary Location:
North America-United States-Pennsylvania-Horsham
Janssen Scientific Affairs, LLC (6120)
Job Function:
Medical Affairs
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