Senior Director, Clinical Lead - Neuropsychiatry

Position Summary

The Senior Director, Clinical Leader (CL) is responsible for development and execution of medical and scientific strategies for late phase compounds (Phase2b/3) and operational implementation through the effective leadership of a cross‑functional Clinical Team. The CL leads the team to develop products in a timely and cost‑effective manner, oversees clinical development plans, protocol development, quality execution of clinical studies, preparation and ownership of clinical study reports, and preparation and approval of essential documents for global regulatory filings.

• Develop and execute the clinical development plan, owning the design of clinical trials and the content of clinical study reports.
• Lead and supervise the cross‑functional Clinical Team, recruiting and developing junior medical staff.
• Act as molecule responsible physician, overseeing medical monitoring, reporting, and safety activities; evaluate adverse events for relationship to treatment.
• Oversee content for the Independent Data Monitoring Committee and adjudication meetings as needed.
• Interpret, report, and prepare results of product research for global health authority submissions and external communication.
• Assess medical publications emerging from the team and its affiliates.
• Assist Regulatory Affairs in development of drug/device regulatory strategies and determine requirements for corrective actions or health authority reporting.
• Act as medical contact at the company for global health authorities concerning clinical/medical issues.
• Serve as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees.
• Explore and evaluate new product ideas to identify new marketing opportunities.
• Support general Clinical/Medical Affairs activities involving product evaluation, labeling, and surveillance.
• Support early clinical development involving product potential and development for registration.
• Manage the budget for all project‑related clinical activities.

• MD (or equivalent) in a relevant area with appropriate post‑doctoral training and certification.
• A minimum of 5years of clinical research or pharmaceutical industry experience, including at least 3years of PhaseII/III development experience.
• A minimum of 3years of highly successful managerial/supervisory or related experience.
• Board Certification or eligibility in Psychiatry or Neurology (preferred).
• Global registration experience strongly preferred.
• Experience working in a matrix environment and interfacing with clinical operations, medical affairs, and marketing.

• Fluent in written and spoken English.
• Working knowledge of Microsoft Office (Excel, Word).
• Knowledge of Good Clinical Practices and regulatory requirements for clinical trials and regulatory filings.

• Clinical Research and Regulations
• Clinical Trials
• Collaborating
• Corporate Governance
• Data Management and Informatics
• Developing Others
• Drug Discovery Development
• Global Market
• Health Care Regulation
• Inclusive Leadership
• Industry Analysis
• Innovation Leadership
• Market Research
• Research Ethics
• Scientific Evaluation
• Scientific Research
• Stakeholder Management
• Strategic Change

The anticipated base pay range for this position is $226,000 to $391,000 USD. This role is eligible for the company’s long‑term incentive program and its consolidated retirement plan (401(k)). Additional employee‑benefit programs include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Time‑off benefits include vacation (120hours per calendar year), sick time (40hours per calendar year;

56hours for Washington State employees), holiday pay (13days per calendar year, including floating holidays), work, personal and family time (up to 40hours per calendar year), parental leave (480hours within one year of birth/adoption/foster care), condolence leave (30days for an immediate family member, 5days for an extended family member), caregiver leave (10days), volunteer leave (4days), and military spouse time‑off (80hours).