Senior Director, Global Clinical Development, Neuroscience

Position Summary

The Clinical Development Lead sits within Clinical Development, a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.

• 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).
• 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.

• 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.

• 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.
• Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post‑marketing development, as well as awareness of the enterprise disease area portfolio.
• Demonstrated sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent.
• Verifiable track record of successful people management and development, or leadership in a matrix team (e.g., mentoring junior colleagues).

• Excellent skills in clinical development strategy including the clinical components of regulatory submission(s).
• External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS.
• Partner and interact with colleagues from Early Development who design and implement first‑in‑human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II‑III trials).
• Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables.

• Domestic and International travel may be required.

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