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SENIOR DIRECTOR, CLINICAL DEVELOPMENT, IMMUNOLOGY
Requisition ID: 7855161004
This position will serve as Senior Director for Clinical Immunology for marketed and investigational products in development, with indications in Rheumatology. The Sr. Director will be responsible for oversight of clinical development programs, including design, execution, and reporting of Phase 2 and 3 clinical trials. He/she will provide the highest-level of scientific expertise through entire clinical trial process including interactions with commercial and all level of management.
Responsibilities for the Senior Director include overall program leadership:
- Designing of Clinical development program (CDP), as well as execution and reporting of trials
- Monitoring safety of clinical trials and providing scientific leadership in the area of responsibility
- Providing scientific & clinical leadership of Phase 2 and 3 clinical trial teams
- Leading the development of the Integrated Study Plans and study summaries, IND submissions, and technical reports
- Providing input to strategic decisions regarding therapeutic indications
- Overseeing 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
- Presenting data and scientific information to the organization at all levels
- Building credible relationships with opinion leaders and external alliances for partnered products when relevant
- Line management accountability for promotions, recruitment strategy and team structure
- May evaluate in-licensing opportunities and contribute to early development programs
Qualifications for the Senior Director include:
- Requires an MD or doctorate level degree (e.g. PhD or PharmD)
- Board certification in a relevant therapeutic area (Rheumatology) is highly desired
- For non-MD candidates, experience in Rheumatology clinical development is highly desired
- A minimum of 5 years of clinical research or clinical trials experience preferably in an industry setting is strongly preferred
- Must have strong planning and communication skills to manage and proactively identify resource issues
- Experience in clinical trial design and medical monitoring is highly desired.
- Prior experience in a leadership role is a must.
- This position may require up to 10% annual travel (domestic and international).
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Clinical Trial Coordination