Senior Director, Clinical Development

Role Summary

The Senior Director, Clinical Development will lead Centessa’s development of sleep-wake disorders and other CNS indications, overseeing study conduct, data interpretation, regulatory submissions, and external partnerships in a matrixed environment. This leadership role will shape the direction and success of the company and involve cross-functional collaboration and strategic input.

Responsibilities

• Author clinical study protocols for orexin agonists
• Provide scientific and medical expertise to execute clinical studies and advance accelerated development programs
• Contribute to the design of a cross-functionally aligned clinical development plan to advance multiple orexin agonist candidate molecules
• Collaborate with clinical operations to meet timeline, cost and quality performance expectations and achieve program milestones
• Provide medical insight and leadership in translational medicine approaches exploring indication expansion opportunities
• Communicate and collaborate across internal disciplines and with external partners/experts/investigators to position orexin agonist programs in sleep disorders
• Provide oversight of study integrity and timelines, and communicate information pertaining to safety and efficacy of clinical candidates
• Author/review clinical sections of regulatory documents, clinical study reports, scientific publications and presentations, and other program documents
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs and quality standards in conducting clinical research

Qualifications

• MD in neurology or psychiatry (board certification preferred)
• Clinical/academic experience in neurological disorders; 5 years of pharmaceutical industry experience
• Translational medicine expertise highly desired
• Experience in early clinical development through late stage with successful design and implementation of proof-of-concept studies; neuroscience submission experience is desired
• Knowledge of US and EU regulatory guidelines and experience with interactions with regulatory agencies
• Outstanding written and verbal communication, with problem solving and cross-functional stakeholder engagement
• Ability to work independently in a fast-paced matrix environment
• Entrepreneurial spirit with high energy and personal accountability

Skills

• Clinical trial design and leadership
• Regulatory strategy and submissions
• Translational medicine and indication expansion planning
• Cross-functional collaboration and external partnership management
• Effective communication and stakeholder engagement

Education

• MD in neurology or psychiatry (board certification preferred)

Additional Requirements

• Remote work available; US-based with approximately 15% travel