Associate Manager Clinical Operations overseeing team management and training at Thermo Fisher Scientific. Collaborating with leadership for project optimization and staff development.
About the role
- 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
Benefits
- health insurance
- savings plan
- pension plan
- disability plan
- long term incentives
- vacation pay
- sick time
- holiday pay
- work, personal, and family time off
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