Senior Medical Director, Clinical Development - Psychiatry

• Lead and manage psychiatry clinical development studies, primarily in major depressive disorder, including study design and medical oversight across development stages.
• Serve as Medical Monitor and collaborate with clinical research sites and investigators globally.
• Prepare and revise Clinical Development Plans for assigned products and candidates with cross-functional colleagues.
• Provide strategic and scientific leadership for standard and novel trial designs in large and rare disease indications.
• Review scientific literature and build product, indication, and therapeutic-area knowledge.
• Serve as therapeutic-area and clinical expert for clinical trial development, execution, communication, and data interpretation.
• Monitor external research and regulatory environments and emerging study data.
• Identify and build relationships with Key Opinion Leaders and other experts.
• Draft and review clinical and scientific sections of INDs, NDAs, Investigator Brochures, protocols, clinical study reports, regulatory submissions, posters, abstracts, and manuscripts.
• Analyze development strategies and options for discovery pipeline programs, including Proof-of-Concept trials and biomarker approaches.
• Support in-licensing, out-licensing, and partner relationships.
• Present proposals and plans to internal and external audiences, including the Executive Leadership Team.
• Contribute to departmental goals, budget planning, and budget management.
• Collaborate with external clinical and other vendors to ensure high-quality, high-integrity data generation.
• Recruit, lead, develop, coach, and evaluate direct reports, if applicable.
• Travel domestically and internationally as required.
• Perform other duties as assigned.

Requirements

• MD or MD/PhD with strong and versatile clinical development experience, ideally in psychiatry and preferably major depressive disorder; neurology experience is an asset.
• Minimum 8 years of progressive development experience in the pharmaceutical industry or related settings; most relevant experience obtained in industry.
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
• Experience developing study concepts and clinical trial designs with cross-functional input, including biostatistics, observational research, and patient-reported outcomes in Phase 3 trials.
• Experience with clinical trials from concept through clinical study report.
• Knowledge of Good Clinical Practices, FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.
• Growth mindset, leadership experience, and leadership potential as a clinical development expert and Medical Monitor in a complex matrix environment.
• Ability to present ideas and document complex medical/clinical concepts in written and oral communication.
• Strong interpersonal skills, problem‑solving abilities, superior judgment, and balanced understanding of issues and resolution paths.
• Ability to work onsite at the Boston office at least two days per week if Boston‑based.
• Ability to travel domestically and internationally as required.
• United States work authorization without restrictions based on citizenship or immigration status.

Core Competencies

Demonstrates extensive clinical development expertise in psychiatry, particularly in major depressive disorder, with a strong focus on study design, regulatory compliance, and strategic leadership in clinical trials. Proven ability to collaborate across functions and present complex medical concepts effectively.

Proven ability to collaborate across functions and present complex medical concepts effectively.