Clinical Development Program Lead, Neuropsychiatry (Executive Director)

Role Summary

The Clinical Development Program Leader sits within Clinical Development, a global organization responsible for the design, execution and interpretation of clinical trials. The role sets the clinical development strategy for assets or indications and directly supervises multiple Clinical Development Leads who supervise individual Clinical Trial Physicians. It includes disease/indication strategy across development teams and collaboration with R&D and GDD to support GT4/5 and POC transitions, providing insights into biology, translational elements and overall benefit-risk assessments. The role also develops differentiated Clinical Development Physicians for multiple transition assets and supports a broad program from Phase I expansion through registrational execution, reporting to the Head of Clinical Development as a core member of the Therapeutic Area clinical development leadership team.

Responsibilities

• Set the clinical development strategy for assets or indications.
• Directly supervise the work of multiple Clinical Development Leads who supervise individual Clinical Trial Physicians.
• Oversee disease/indication strategy across several development teams and supervise broad Clinical Development activities; provide insights into biology, translational elements and overall benefit-risk assessments.
• Supervise the development of differentiated and strategic Clinical Development Physicians for multiple transition assets and support a broad program from Phase I expansion through registrational execution.
• Support across portfolio activities in line with Clinical Excellence, including Protocol Review Committee, support of Business Development activities and Quality and Compliance leadership.
• Report to the Head of Clinical Development and deputize as required; be a core member of the Therapeutic Area clinical development executive leadership team.
• Strategy and Execution: Create and communicate a vision for designing, conducting and executing innovative clinical development plans.
• Provide strategic insights into the clinical development plans; supervise the development, monitoring, analysis and interpretation of clinical trials and regulatory filings.
• Contribute to overall strategy for specific disease/indications while ensuring a franchise-wide portfolio view.
• Lead search and evaluation activities on business development due diligence and advise the strategic transactions group.
• Be a key member of the Therapeutic Area Clinical Development Leadership Team and chair forums as required.
• Chair departmental staff meetings and represent governance meetings on an ad hoc basis.
• 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.
• Leadership and Matrix Management: Lead and develop a group of Clinical Development professionals (up to 50 direct and indirect) whose focus is a specific disease area/indication; recruit, develop and retain talent; mentor staff; foster an ethical, diverse, collaborative culture; manage budget and headcount.
• Stakeholder Engagement and Communication: Work with colleagues across Research, Development, Regulatory, Medical, Commercial and other functions globally; build external relationships and be recognized as an expert; ensure a seamless transition from early development to late-stage trials.
• Governance Participation and Signature Authority: Participate in governance ad hoc; serve as PRC Chair ad hoc; hold signature authority for CSRs, Health Authority Briefings, DMC Charters, unblinding requests, and other clinical documents as delegated.

Qualifications

• MD (PhD or other high level degree optional).
• 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 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 Neuropsychiatry 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 Neuropsychiatry clinical development strategy.
• Proven track record in managing complex clinical programs leading to regulatory submissions.
• Deep understanding of Biology, targets and translational science.
• Extensive experience of work with health authorities at all levels.
• Proven differentiated 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.
• The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory.
• The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment.
• In addition, the candidate must be skilled at interacting externally, and at speaking engagements.
• Must be skilled at attracting, developing, and retaining skilled professionals.

Additional Requirements

• Domestic and International travel may be required.