Role Summary
Clinical Development Program Lead, Neuropsychiatry (Executive Director) responsible for setting clinical development strategy across assets or indications, supervising Clinical Development Leads and Clinical Trial Physicians, and guiding cross-functional teams through Phase I–III and lifecycle management within Neuropsychiatry.
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 clinical components of regulatory filings.
- Contribute to strategy for specific disease/indications while maintaining an overall franchise portfolio view.
- Provide strategic insights into clinical development plans.
- Lead due diligence and advise on strategic transactions related to business development.
- Serve as a Key Member of Therapeutic Area Clinical Development Leadership Team; chair governance forums as needed.
- Chair departmental staff meetings and represent governance meetings as required.
- Build a franchise reputation to attract external innovators to the program.
- Develop strategies for lifecycle management beyond commercialization and launch.
Qualifications
- MD required; PhD or other high-level degree optional.
- Greater than 10 years of extensive clinical trial, drug development, and regulatory experience; strong scientific background.
- Management experience leading a group of professionals with clinical research experience; ability to recruit, develop and retain talent.
- Experience designing and conducting Phase I–III trials; successful regulatory filings through approval; global experience in Neuropsychiatry is a plus.
- Experience with business development and licensing to evaluate in-licensing opportunities shaping Neuropsychiatry strategy.
- Proven track record in managing complex clinical programs leading to regulatory submissions; strong translational science understanding; experience with health authorities.
- Ability to work in a matrix environment and interact with Commercial, Medical, Research, Regulatory teams and external stakeholders.
Skills
- Strategic thinking and execution in clinical development.
- Leadership and matrix management of large cross-functional teams (up to 50 staff).
- Stakeholder engagement with internal and external partners, thought leaders, physicians, and patient groups.
- Regulatory affairs and the ability to contribute to regulatory filings and interactions with health authorities.
- Strong communication, governance, and decision-making capabilities.
- Talent development, diversity of thought, coaching, accountability and integrity.
Education
- MD required; PhD or other advanced degree optional.
Additional Requirements
- Domestic and international travel may be required.