Clinical Development Lead – Senior Director – Neuroscience
| Company | Bristol Myers Squibb |
|---|---|
| Location | Cambridge, MA, USA, Summit, NJ, USA, San Diego, CA, USA, Lawrence Township, NJ, USA |
| Salary | $313200 – $409900 |
| Type | Full-Time |
| Degrees | MD |
| Experience Level | Expert or higher |
Requirements
- MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
- At least 10 years of relevant experience
- Demonstrated leadership in the design and execution of multiple clinical trials
- Able to synthesize internal and external data to produce a clinical strategy
- Able to ensure that the clinical program will result in a viable registrational strategy
- Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts
- Verifiable track record of successful people management and development, or leadership in a matrix team
Responsibilities
- Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication
- Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
- May serve as CTP as necessary
- Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs
- Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
- Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
- Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
- Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
- Serves as the (co-)leader of the cross-functional Clinical Development Team
- Provides clinical leadership and disease area expertise into integrated disease area strategies
- Partners closely with KOLs in specific indications
- Serves as Primary Clinical Representative in Regulatory interactions
- Evaluates strategic options against a given Target Product Profile (TPP)
- Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
- Sets executional priorities and partners with CTP and CS to support executional delivery of studies
- Accountable for top line data with support of CTP, CS, and Statisticians
Preferred Qualifications
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No preferred qualifications provided.