Description
Our client is a Pre-IPO Oncology Biotech based in Santa Monica, Los Angeles, looking for a Head of Clinical Science. The title of the role is experience-dependent and can be anything from Senior Director to VP of Clinical Science. This well-funded company offers a competitive compensation package, as well as the opportunity to join on the ground floor. This role is hybrid.
- Responsible for all aspects of clinical trial design, planning, and execution
- Create Clinical Development Plans for review/input from the head of development
- Support regulatory filings
- Support Business Development activities from a clinical development perspective
Experience
- Proficient knowledge of oncology, GCP/ICH, drug development, study design, statistics, biomarkers, pharmacokinetics, clinical operations in order to lead clinical trials
- Experience managing outsourced clinical studies (insourced or outsourced)
- Demonstrated success as a clinical trialist working closely with/leading team of colleagues in medical, safety, statistics, biomarkers, clinical pharmacology, regulatory, and quality assurance
- Ability to work independently, be self-motivated, set priorities, handle multiple tasks and projects with a high degree of efficiency and comfort with ambiguity
- Operate with a high degree of autonomy and professionalism in a fast-moving start-up environment
- 10+ years of experience in pharmaceutical R&D, target discovery or similar in a biotech, pharmaceutical or similar company
- Experience leading IND/CTA and NDA/BLA/MAA filings
Educational requirements
- Degree in Life Sciences (MD, PhD, PharmD, MS, RN or other)
- 5-10 years' experience in clinical science, clinical research, clinical development or equivalent in oncology