Responsible for the development and execution of the clinical development plan
Leads Cross-functional Clinical Team; supervises, develops and recruits junior medical staff
Responsible for the oversight of medical monitoring/reporting and safety activities
Responsible for overseeing content for the Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed
Prepares results of product research in preparation for global health authority submissions
Assists Regulatory Affairs in the development of drug/device regulatory strategies
May act as company spokesperson regarding publication of clinical research findings
Helps explore and evaluate new product ideas

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
A minimum of 3 years of Phase II/III development experience within industry
Board Certification or Eligibility in Psychiatry or neurology preferred
Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required
Global registration experience strongly preferred
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

Senior Director, Clinical Leader – Neuropsychiatry

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