WWDA is recruiting for a Director of Clinical Development. At J&J, we are working to transform lives by finding new and better ways to prevent, intercept, treat and cure disease. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. At Johnson and Johnson World Without Disease Accelerator (WWDA), we envision a world where widespread disease is a historical artifact, where all people live healthier lives promoted by technological and medical advances. We aim to advance scientific strategies and solutions to predict, preempt, and delay the progression of serious diseases. Our current focus is in type 1 diabetes and early childhood health conditions, such as atopic dermatitis and food allergy.
The incumbent will provide scientific, clinical and operational direction of WWDA T1D clinical programs, including oversight of planned and ongoing clinical trials and observational studies of pharmaceutical, medical device and/or consumer products/solutions. Responsibilities include participating in the design of clinical programs and protocols, conduct and supervision of clinical trials guided by highest standards of ethical and good clinical practices, development of clinical relationships with internal and external partners, analysis and reporting of trial results and interactions with global regulatory agencies.
- Design and approval of clinical trials and design/implementation of protocols to meet those objectives.
- Supervision and/or implementation of high standards of research conduct.
- Identify and propose new research of development projects and assess the feasibility of pursuing these projects.
- Represent WWDA at presentations to senior management. Examples: Development Committees, First in Human Committee as well as GOC, Executive Committee, corporate partners, global regulatory agencies and the public at scientific meetings.
- Oversee the preparation of clinical portions of regulatory documents including IBs, IDEs, INDs, briefing books, BLAs/PMAs and other regulatory submissions.
- Responsible for participating in strategic direction setting for WWDA including presentation at WWDA Core Team meetings, leadership meetings and in evaluating new business or scientific opportunities.
- Ability to work cross-sector in consumer products, pharm, and/or medical device spaces
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
- MD degree required. Endocrinology specialty is a plus.
Required Experience and Skills
- 4 years of clinical/biomedical research experience in or outside of industry setting is required.
- Experience in early and late stage clinical development required.
- Ability to successfully work in a matrixed environment and with both internal and external stakeholders and KOLs required
- Demonstrated ability to present scientific content to diverse audiences required
- This role is located in Horsham, PA with up to 20 to 30% travel both US and international. Are you willing and able to meet this requirement?
- Learning agility and ability to works across multiple sectors (pharm, medical device, and or consumer) preferred
- Previous experience in people leadership preferred
- Excellent written and verbal communication skills
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Horsham-850 Ridgeview Drive
Janssen Research & Development, LLC (6084)