Executive Director, Clinical Development Program Lead (Neuropsychiatry)
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Lead the clinical development strategy for neuropsychiatry assets or indications, overseeing multiple clinical development leads and ensuring scientific and technical excellence of programs. This role involves driving strategy from early-stage transitions through registrational execution and leading a team of up to 50 clinical development professionals.
Responsibilities
- Set the clinical development strategy for neuropsychiatry assets or indications
- Directly supervise multiple Clinical Development Leads including Clinical Trial Physicians
- Oversee disease/indication strategy across several Development teams
- Provide insights into biology, translational elements, and benefit-risk assessments for GT4/5 and POC transitions
- Supervise the development of differentiated and strategic Clinical Development Physicians for multiple transition assets
- Support across portfolio activities consistent with Clinical Excellence (e.g., Protocol Review Committee, Business Development, Quality and Compliance)
- Create and communicate an innovative vision for designing, conducting, and executing clinical development plans
- Lead and develop a group of Clinical Development professionals (up to 50 individuals, direct and indirect)
- Build a franchise reputation that attracts innovators to bring ideas to BMS
- Partner and interact with colleagues across BMS Research, Development, Regulatory, Medical, and Commercial
Requirements
- MD degree
- 10+ years of extensive clinical trial, drug development, and regulatory experience
- Strong scientific background
- Management experience leading MDs, PhDs, or PharmDs with clinical research experience
- Understanding of early-stage drug development
- Extensive experience designing and conducting Phase I, II, and Phase III clinical trials
- Demonstrable success filing and prosecuting regulatory dossiers through approval
- Proven track record in managing complex clinical programs leading to regulatory submissions
- Deep understanding of Biology, targets, and translational science
- Extensive experience working with health authorities at all levels
- Proven ability to support and manage across the totality of the spectrum including development of registrational and non-registrational trials
- Proven ability to execute the BMS R&D People Strategy and lead and develop a matrix team
- Effective leader capable of working with Commercial, Medical, and all research functions
- Skilled at interacting externally and at speaking engagements
- Skilled at attracting, developing, and retaining skilled professionals
Qualifications
- MD (PhD or other high-level degree optional)
- Greater than 10 years of extensive clinical trial, drug development, and regulatory experience, with a strong scientific background. Management experience is important.
Nice to Have
- PhD or other high-level degree
- Global experience in oncology clinical research
- Experience interacting with business development and licensing