Senior Director responsible for development and execution of clinical strategies for neuropsychiatry at Johnson & Johnson. Leading cross-functional teams to ensure timely and effective product development.
Responsibilities
Responsible for the development and execution of the clinical development plan
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 Independent Data Monitoring Committee (IDMC)
Interprets, reports and prepares results of product research
Assists Regulatory Affairs in the development of regulatory strategies
Acts as medical contact at company for global health authorities concerning clinical/medical issues
Manages the budget for all project related clinical activities
Requirements
MD (or equivalent) in relevant area with appropriate post-doctoral training and certification
A minimum of 5 years clinical research or pharmaceutical industry experience
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
Global registration experience strongly preferred
Experience working in a Matrix environment
Ability to interface effectively with clinical operations, medical affairs and marketing
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