Director/Sr. Director, Clinical Scientist

The Director/Sr. Director, Clinical Scientist is responsible for working as an extension of the Clinical Development team for all aspects of the clinical trial design, execution and oversight. The Director/Sr. Director is responsible for drafting and/or reviewing all required clinical documents, conducting data review and safety oversight, liaising with internal and external members of the trial team.

Major Duties and Responsibilities (including supervising others):

  • Support the clinical lead in clinical science aspects of the program
  • Provide clinical input to the clinical development plan at all stages
  • Leads, approves or provides input for the protocols, amendments, and other relevant strategic documents.
  • Provide input and hold accountability for the development of crucial study level documents (i.e. Clinical study Protocol)
  • Attends (in person or by TC) the Site Initiation Visits, to present the study design and protocol
  • You will develop and design studies to determine the scientific and clinical viability of a particular drug or portfolio of drugs and interpret trial results, either as the head of a team, or by providing expert input.
  • Integrate the biology, translational and clinical science into the program strategy
  • Leads (or supports, as required) the preparation of clinical and other data for interactions, board meetings and other presentations
  • Leads (or support, as required) the preparation of program level documents such as the investigators brochure and DSUR informed consent form.
  • Leads/supports the collaboration with the scientists to provide clinical input to the development and review of data to support development of the candidate drug investment decision compounds
  • Follows important developments and trends in the medical & scientific literature and disseminates updates to the project team and beyond ensuring all involved parties are aware of key developments and the impact on the strategy
  • Leads or supports the development and review of content and quality of publications and inputs to development of the publication strategy
  • Where required leads project specific reviews of the competitor landscape to inform the program strategy

Minimum Requirements –Education and Experience.

  • Relevant Clinical or Biomedical Ph.D. or relevant Pharmacy, Nursing, MSc/MRes degree; will consider M.S. with additional clinical and operational experience
  • Demonstrated scientific acumen and mechanistic understanding of drug development, human disease states and early research and development preferred Clinical drug development within a pharmaceutical/biotech or academic environment
  • Successful candidates will be self-motivated and scientifically rigorous with flexibility for fast-paced industry
  • Advanced understanding of evolving clinical practice with the introduction of new therapies.
  • Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and lead through conflict
  • Problem solving and issues management
    A good understanding of the pharmaceutical and clinical drug development process
  • May act as a coach and/or mentor for other more junior staff, as required