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