Senior Director, Clinical Lead – Neuropsychiatry

Responsibilities

• Responsible for the development and execution of the clinical development plan and has ownership for the design of clinical trials and for the content of clinical study reports.
• Leads Cross‑functional Clinical Team; supervises, develops and recruits junior medical staff.
• Responsible for the oversight of medical monitoring/reporting and safety activities; evaluates adverse events (pre‑ and post‑marketing) for relationship to treatment.
• Responsible for overseeing content for the Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed.
• Interprets, reports and prepares results of product research in preparation for global health authority submissions and external communication.
• Responsible for assessment of medical publications emerging from the Team and its affiliates.
• Assists Regulatory Affairs in the development of drug/device regulatory strategies and determining requirements for any corrective actions or health‑authority reporting.
• Acts as medical contact at company for global health authorities concerning clinical/medical issues.
• May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees.
• Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities.
• Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance.
• Supports early clinical development involving product potential and development for registration.
• Manages the budget for all project‑related clinical activities.

• MD (or equivalent) in relevant area with appropriate post‑doctoral training and certification.
• A minimum of 5 years clinical research or pharmaceutical industry experience is required, inclusive of a minimum of 3 years of Phase II/III development experience within industry.
• Board Certification or Eligibility in Psychiatry or neurology preferred.
• A minimum of 3 years of highly successful managerial/supervisory or related experience.
• Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required.
• Global registration experience strongly preferred, as is experience working or interacting with Health Authorities.
• Experience working in a Matrix environment is required.
• Ability to interface effectively with clinical operations, medical affairs and marketing is essential.
• Fluent in written and spoken English.
• Working knowledge of the use of Microsoft suite of software products including Excel and Word.
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings.