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Director Clinical Development, Immunology
Requisition ID: 2761180205
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Clinical Development, Immunology to be located in Spring House, 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 Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
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.
This position will serve as a Director for Clinical Immunology products in development with indications in Gastroenterology. The position will support protocol design, development and execution, will participate in investigator meetings, and participate in the conduct of clinical trials. In addition the incumbent would be expected to have strategic input in study design, regulatory interactions and document writing.
- Responsible for design, execution, and reporting of Phase 2 and 3 clinical trials.
- Responsible for monitoring safety of clinical trials and providing scientific leadership in the area of responsibility.
- Provides scientific & clinical leadership of Phase 2 and 3 clinical trial teams.
- Leads the development of the Integrated Study Plans (concept sheets, project plans, protocols, CRFs, operational and analytic plans) and study summaries, IND submissions, and technical reports. Provides input to strategic decisions regarding therapeutic indications.
- Oversees the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions.
- Authorship of abstracts and manuscripts for publication based on clinical trial data.
- Presents data and scientific information to the organization at all levels.
- Builds credible relationships with opinion leaders and External alliances for partnered products when relevant
Qualifications for the Director Clinical Development, Immunology include:
- MD or DO is required
- Board Certification in Gastroenterology would be desirable
- Experience in pharmaceutical drug development (academic or industry setting) is highly desirable
- Experience in clinical trial monitoring is an asset
- Ability to work in a matrix environment with cross functional teams is essential
- Strong leadership skills and the ability to influence is necessary
- Approximately 10% to 20% annual travel may be required (domestic and international)
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Clinical Research MD