Director Clinical Development, GI-5189141017
Description
Janssen Research & Development, L.L.C., a member of Johnson and Johnson's Family of Companies is recruiting for a Director, Clinical Development, GI to be located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
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 Development will be responsible for the development and execution of clinical programs within Gastroenterology within the Immunology therapeutic area. The successful candidate will consult and assist in direction for early phase (phase 0/I) clinical development for selected NMEs across multiple GI indications. They will work closely with leadership in informing, influencing and implementing strategies for all aspects of clinical development. They will design, implement and reporting of phase II and III clinical trials and support of resulting regulatory submissions.
Some of the essential responsibilities for the position include: Design and approval of Clinical trial and design/implementation of protocols to meet those objectives and provide clinical expertise through entire clinical trial process; Development of Safety monitoring plan; Identify and propose potential new research or development projects and assess feasibility in pursuing these projects; Oversee and or prepare clinical portions of INDs, BLAs and other regulatory submissions; Preparation of Investigator Brochure; CRF development; Reviewing the clinical content of status reports for upper management and clinical/project team use; Assisting in financial negotiations and contract development with third party vendors (e.g. consultants, CROs, and investigation sites); Assist in the development, management and tracking of the departmental/project budget; Maintain liaison with individuals and groups within the organization for purposes of information, communication, technology transfer and collaboration and Represent Immunology Clinical Research at presentations senior leadership, board of directors, corporate partners, regulatory agencies and the public.
Qualifications
This position requires a MD, DO, PhD or PharmD degrees. Board Certification or Board Eligibility in Gastroenterology is preferred, candidates who are board certified in other medical specialties or those who have a PhD in relevant scientific disciplines or Pharm D will also be considered . A minimum of 2 years experience in clinical research/development in academia, CRO and/or the pharmaceutical industry or a Gastroenterology fellowship is strongly preferred. Ability to work in a matrix organization with cross functional reams is required. Excellent leadership, oral and written communication/presentation skills are required. This position may require up to 20% annual travel (domestic and international).
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J2W: LI NA
Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Research MD
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