Executive DirectorVP Clinical Development
Executive DirectorVP Clinical Development
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1 Vacancy
Job Description
Job Title: Executive Director/VP Clinical Development(Remote)
Job Location: Shelton WA 98584 USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Executive
Responsibilities
Design plan and provide medical oversight of clinical studies across all phases of development.
- Collaborate with Clinical Operations on study implementation and act as the Medical Monitor.
- Oversee the interpretation and dissemination of study results including clinical study reports and publications.
- Serve as a core member of the clinical development team contributing to overall clinical strategy and ensuring compliance with applicable regulations.
- Support executive leadership by providing medical input into clinical program design strategic planning and tactical execution.
- Provide oversight of clinical programs ensuring execution and completion of clinical trials in alignment with regulations ICH/GCP guidelines and internal SOPs.
- Partner with Clinical Operations to ensure timely and compliant completion of all clinical study activities.
- Review clinical data from all phases of development assisting in the generation of study reports and publications.
- Manage communication and collaboration with internal departments (e.g. Legal Regulatory Drug Safety Finance) and external vendors (e.g. CROs consultants) to achieve study objectives.
- Develop and implement SOPs for clinical trials and ensure compliance with regulatory standards.
- Build and maintain professional relationships with academic and communitybased study sites.
- Provide executive management with updates on project scope schedule and resource needs.
- M.D. degree preferred with expertise in neuroscience (psychiatry neurology) or significant clinical trial experience in neuroscience.
- Minimum of 9 years of experience in the biotechnology/pharmaceutical industry including 5 years in clinical trials management or clinical development leadership.
- Demonstrated ability to design manage and execute clinical trials across all phases of development.
- Strong knowledge of FDA and ICH regulations as well as clinical medicine pharmacology and related disciplines (e.g. biostatistics data management medical writing).
- Expert knowledge of Good Clinical Practice (GCP).
- Proven ability to manage multiple projects in parallel ensuring attention to detail and timely resolution of issues.
- Excellent project planning leadership negotiation and presentation skills.
- Significant experience communicating complex information to senior management and crossfunctional teams.
- Highly motivated entrepreneurial mindset with the ability to drive results in a fastpaced environment.
- Strong ability to build effective relationships with internal teams and external partners.
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Employment Type
Full Time
