Vice President, Clinical Development

We are seeking a VICE PRESIDENT, Clinical Development to join our team. The VP, Clinical Development will report to the CMO and will be a key contributor to THE COMPANY’S Development Team. The VP will be involved in the planning and execution of clinical trials for one or more programs within predefined timelines and budgets while ensuring regulatory compliance. The VP will provide input and presentation of materials to support the development programs. The incumbent will help establish and maintain external collaborations with Key Opinion Leaders (KOL) and other collaborators. The VP will provide input into clinical and regulatory strategies and documents such as Investigator Brochures, Clinical Trial Applications and IND filings.

Duties and Responsibilities:

  • Providing strategic input into clinical and regulatory development plans
    • Input on regulatory documents for submissions/discussions with Health Authorities on clinical data
    • Lead in developing clinical trial protocols
    • Participate in the planning and management of advisory boards, investigator meetings, and other scientific committees
    • Participate and contribute to the collection and review of patient safety data
    • Writing and reviewing study reports, and regulatory documents
    • Participating in the selection and oversight, and management of contract research organizations (CROs) and other vendors
    • Collaboration with clinical operations personnel to ensure coordinated project planning
    • Collaborating with pre-clinical colleagues to assess the need for and design of appropriate preclinical experiments to support the development plan
    • Contribute to development of publication plan and clinical data communication
    • Collaborate with business development to develop stage appropriate commercial assessments
    • Provide analyses of development strategies and options for discovery pipeline programs

Requirements:

  • A minimum of 6 years in clinical development experience with MD
  • Broad experience in clinical trial design, data analysis, interpretation and clinical relevance
  • Good knowledge of FDA and EMA regulations, Good Clinical Practice, ICH guidelines, and clinical drug development
  • Excellent verbal and written skills.
  • Proficient in Microsoft Office applications.
  • Strong ability to work collaboratively in a dynamic fast paced environment.

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