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).
Requisition ID: 7855161004