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Clinical Development Program Lead, Neuropsychiatry (Executive Director)

Bristol Myers Squibb
Full-time
Remote friendly (Madison, NJ)
United States
Clinical Research and Development

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Role Summary

The Clinical Development Program Lead, Neuropsychiatry (Executive Director) leads strategy and execution of clinical development across assets or indications within Neuropsychiatry, supervising multiple Clinical Development Leads and coordinating with R&D, Regulatory, Medical, and other functions to advance programs from early development through registrational stages.

Responsibilities

  • Create and communicate a vision for designing, conducting and executing innovative clinical development plans
  • Supervise the development, monitoring, analysis and interpretation of clinical trials and oversee the clinical components of regulatory filings
  • Contribute to overall strategy for specific disease/indications while maintaining a franchise-wide portfolio view
  • Provide strategic insights into clinical development plans
  • Lead search and evaluation activities on business development due diligence efforts and advise the strategic transactions group
  • Serve as a Key Member of Therapeutic Area Clinical Development Leadership Team and chair forums as required
  • Chair departmental Staff Meetings and represent governance meetings as needed
  • Build a franchise reputation that attracts innovators to bring ideas to the organization
  • Develop strategies to extend programs beyond commercialization into lifecycle management

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 supervising a group of professionals (MDs/PhDs/PharmDs) with clinical research experience
  • Experience designing and conducting Phase I–III trials and prosecuting regulatory dossiers through approval
  • Global experience in Neuropsychiatry clinical development is a plus
  • Experience with business development and licensing to shape Neuropsychiatry strategy

Key Competency Requirements

  • Proven track record in managing complex clinical programs leading to regulatory submissions
  • Deep understanding of biology, targets and translational science
  • Extensive experience with health authorities at all levels
  • Ability to oversee registrational and non-registrational trials across the development spectrum
  • Ability to execute R&D People Strategy and lead a matrix team
  • Strong cross-functional leadership across Commercial, Medical, Research, and Regulatory
  • Skilled at external interactions and speaking engagements
  • Ability to attract, develop, and retain skilled professionals

Travel Required

  • Domestic and international travel may be required