Executive Director, Clinical Development Program Lead (Neuropsychiatry)

Role Summary

Executive Director, Clinical Development Program Lead (Neuropsychiatry) within Clinical Development. Leads strategy and execution of clinical development plans for assets or indications, supervising multiple Clinical Development Leads and Clinical Trial Physicians, and contributing to disease/indication strategy across a portfolio from early-phase expansion through registrational execution.

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 diseases/indications while maintaining a franchise-wide portfolio view
• Provide strategic insights into clinical development plans
• Lead due diligence efforts for business development and advise 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 as needed
• Build a franchise reputation that attracts innovators to bring ideas to the company
• Develop strategies to extend programs beyond commercialization into lifecycle management
• Lead and develop a group of Clinical Development professionals (up to 50 staff, direct and indirect) across a disease focus
• Recruit, develop and retain talent; mentor staff
• Foster an effective, ethical culture supporting teamwork, peer review, cooperation, accountability and continuous improvement
• Oversee team budget and headcount
• Engage with Research, Regulatory, Medical, Commercial and other functions; build external relationships with thought leaders and patient advocacy groups
• Coordinate with Research and Early Development to ensure transition from first-in-human to late-stage trials
• Participate in governance; execute signature authority for clinical documents as designated

Qualifications

• MD required; PhD or other high-level degree optional
• Greater than 10 years of clinical trial, drug development and regulatory experience; strong scientific background
• Management experience leading professionals with clinical research backgrounds
• Deep understanding of early-stage drug development and experience designing and conducting Phase I‚ÄìIII trials
• Experience filing regulatory dossiers and prosecuting through approval
• Global experience is a plus, particularly in oncology across geographies
• Experience with business development and licensing to shape oncology clinical development strategy

Key Competencies

• Proven track record 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
• Ability to manage across the full spectrum of trials including registrational and non-registrational
• Experience executing R&D people strategy and leading a matrix team
• Ability to collaborate across Commercial, Medical, and Research functions
• Comfort with cross-functional teams and matrix environment
• Skilled at external interactions and speaking engagements
• Ability to attract, develop, and retain skilled professionals

Travel & Additional Requirements

• Domestic and international travel may be required

Education

• MD required; PhD or other advanced degree optional