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Head of Clinical Operations (CNS)

Company: Michael Page
Location: Cambridge
Posted on: March 17, 2023

Job Description:

This Executive Director / Head of Clinical Operations will lead psychiatric programs. Highly visible role expected to interact with the executive team, design Clinical Studies, and build and manage CRO relationships.Ideally, candidates are to have 15+ years of experience managing clinical trials execution in biotech / pharma and experience in CNS or psychiatric programs is preferred.Client DetailsThis client is a rapidly growing clinical-stage biotech based in the Boston area which develops treatments for multiple deadly diseases. The publicly-traded company is cash rich has a robust pipeline with 20+ product candidates and several with a strong outlook for commercialization.Description

  • Provide leadership in Clinical Operations across psychiatric programs.
  • Developing, implementing, and/or managing adequate systems and procedures to ensure efficient day-to-day operations that meet the business and its affiliates' clinical trial needs.
  • Assisting with clinical trial vendor selection and selection of vendor personnel to meet clinical trial planning, execution and clinical trial obligations for the company. This may include the following personnel from vendors: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, and Medical Writers.
  • Ensuring compliance with established clinical and regulatory guidelines, operating systems and procedures in clinical trials and maintaining Clinical Operations training including reviewing training of vendor personnel and external contractors.
  • Outlining the scope of clinical trial programs with resource needs, timelines, and cost of services
  • Deploying resources, as necessary, for each new project and ensuring that clinical program and trial objectives have been properly communicated to key personnel (e.g., Project Managers, and other functional areas).Profile
    • Minimum education: M.S. / B.S. in a scientific or health-care related discipline.
    • Minimum experience: 15 years in leading clinical trials execution.
    • Track record of successfully managing large, global multi-center clinical studies for a pharmaceutical and/or biotechnology company.
    • Experience in IND and CTA submissions.
    • Experience with psychiatry or CNS preferred.
    • Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
    • Clear written and verbal expression of ideas, an active/proactive communicator.
    • Proven ability to interact, train, and build strong relationships with CROs, vendors and clinical monitors.If interested, apply for immediate consideration.Resumes and availability may be sent to abbymcgrath (at) Offer
      • Competitive base salary for biotechnology industry
      • Strong financial health ($400m+ across portfolio)
      • Annual bonus
      • Excellent benefits package
      • Equity
      • Top level strategic Head position
      • Member of executive leadership team
      • Ability to hire and grow team in the future
      • Novel drug portfolio with strong pipelineMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Keywords: Michael Page, Cambridge , Head of Clinical Operations (CNS), Other , Cambridge, Massachusetts

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