Executive Director, Global Clinical Development (Neuroscience)

Position Summary

The Clinical Development Program Leader sits within Clinical Development, which is 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. The Clinical Development Program Leader will set the clinical development strategy for assets or indications.

The Clinical Development Program Leader will directly supervise the work of multiple Clinical Development Leads who will in turn supervise individual Clinical Trial Physicians unless otherwise indicated. This role will include above disease / indication strategy work (i.e. supervising Broad Clinical Development teams across several Development teams, as well as Disease / Indication Strategy teams etc.). The role will be foundational in working with teams in R & ED and GDD to support GT4/5 and POC transitions, providing insights into biology, translational elements as well as overall benefit risk assessments. The role will supervise the development of differentiated and strategic Clinical Development Physicians (CDPs) for multiple transition assets and support a broad program of work from phase I expansion through to registrational execution. The role includes support of across portfolio activities in line with Clinical Excellence, including e.g. Protocol Review Committee, support of Business Development activities and Quality and Compliance leadership. The role will report directly to the Head of Clinical Development and will deputize as required, and will be a core member of the Therapeutic Area clinical development executive leadership team.

Key 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 will supervise and have accountability for the clinical components of regulatory filings

• Contribute to overall strategy for specific disease / indications while ensuring a franchise overall portfolio view

• Provide strategic insights into the clinical development plans

• Lead search and evaluation activities on business development due diligence efforts, and advice to our strategic transactions group

• Be a key member of the Therapeutic Area Clinical Development Leadership Team and chairing forum as required

• Build a franchise reputation that attracts innovators to bring their ideas to BMS

• Drug Development Experience

• Create a Clinical Development strategy to develop programs beyond commercialization and launch and into lifecycle management

• Lead and develop a group of Clinical Development professionals (team of up to 50 individuals both direct and indirect)

• Recruit, develop and retain strong talent

• Mentor staff

• Establish an effective and ethical culture that encourages teamwork, peer review, promotes cooperation and provides a supportive culture

• Develop a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and supports process excellence and continuous improvement

• Oversee team budget and headcount

• Stakeholder Engagement and Communication

• Work closely with colleagues in BMS Research, Development, Regulatory, Medical, Commercial and other key functional areas on a global basis; additionally should have an external focus and build relationships with thought leaders, physicians, and patient advocacy groups outside of BMS.

• Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof of concept trials and will assure a seamless transition into late stage development (Phase II-III trials.)

• Governance Participation and Signature Authority

• Governance participation ad hoc as designated

• PRC Chair ad hoc as needed

• Signature Authority for:

  • CSRs
  • Health Authority Briefings
  • DMC Charters
  • Unblinding Requests
  • Health Authority Documents for Filings
  • And other clinical accountable documents delegated as needed

Qualifications & Experience

• MD (PhD or other high level degree optional)

• Experience Requirements

• The ideal candidate will be a clinical development leader; with greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong scientific background

• Management experience will be important since this individual will manage a group of professionals including MDs or PhDs or PharmDs with clinical research experience

• The successful candidate will understand early-stage drug development, extensive experience designing and conducting Phase I, II and Phase III clinical trials, and should have demonstrable success filing regulatory dossiers and prosecuting them through approval

• Global experiences is a plus since this position has responsibility for strategy and clinical research in oncology in multiple geographies

• Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities that shape the oncology clinical development strategy