Associate Director, Clinical Development

Responsibilities

• Serve as a responsible member and clinical science representative on global development teams
• Collaborate with cross-functional partners to provide clinical development expertise in support of study execution
• Provide therapy-area medical and scientific expertise in the evaluation and presentation of clinical trial data
• Write and edit clinical protocols, clinical study reports, manuscripts, and other study-related documents
• Support the quality, coordination, and timeliness of clinical sections of regulatory deliverables (e.g., INDs, Investigator Brochures, CTAs, ISS/ISE, clinical expert reports) in partnership with Regulatory Affairs and Project Management
• Review and monitor patient-level and study-level data, including participation in blinded data review and use of data science approaches as applicable
• Collaborate with statisticians and programmers on statistical analysis plans and interpretation of clinical data
• Work with Medical Writing to support abstracts, manuscripts, and presentations for external scientific meetings
• Act as the clinical science lead to CROs and external vendors, with appropriate oversight from senior leadership
• Contribute to a culture of innovation, collaboration, and continuous improvement
• Perform additional responsibilities as assigned by leadership

Qualifications

• Doctoral degree required (PhD, MD, PharmD, PsyD, MA, LCSW)
• Minimum of 3 years of clinical development experience
• Experience in CNS development (psychiatry or neurology) strongly preferred
• Strong understanding of late-stage clinical development and regulatory processes
• Experience in data review, analysis, and regulatory writing (e.g., IND and CTD sections)
• Demonstrated ability to work collaboratively across functions
• Excellent written and verbal communication skills

Other Skills & Requirements

• Managerial experience a plus
• Proven ability to anticipate challenges and propose thoughtful, evidence-based solutions
• Willingness to travel as required, including international travel (typically 10–20%, may reach higher during peak periods)