Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy. Our therapeutic pipeline consists of immuno-oncology programs against novel drug targets we discovered computationally, including T cell immune checkpoints and additional early-stage immune-oncology programs including myeloid targets. As we advance our pipeline, we are looking for a highly motivated clinician with industry experience to lead a clinical development team including providing strategic leadership of drugs in the pipeline.
The VP of clinical development is a member of the clinical team who will be accountable for deliverables relating to all aspects of clinical development from development input into the advancement of candidate drugs, study concepts, protocol development, oversight of clinical publications, data review and analysis and regulatory submissions. The desired candidate will be accountable for the overall strategy of the clinical development team including budget, staffing and oversight of CROs and alliance partners. The ability to function independently and interact with cross-functional groups to drive the business and teams forward is a key requirement for this position. This position reports to the Chief Medical Officer.
- Leads the development of and ensures compliance with regulatory guidance (eg FDA, ICH, GCP), SOPs, policies, and guidelines
- Thorough knowledge of global regulatory guidance eg US, EU and APAC
- Leads strategic decision making within clinical development
- Leadership skills and ability to interact and function with cross-functional teams in the organization eg biometrics, clinical operations, safety/pharmacovigilance, preclinical teams
- Trained physician (MD), with training/expertise in medical oncology
- 12+ years of industry experience (pharma, biotech)
- Phase 1-3 clinical drug development expertise in oncology, hematology
- Prior experience managing a team of clinicians, clinical scientists
- Prior global regulatory filing experience such as IND, NDA/BLA
- Expertise in the principles and techniques of clinical study design, data analysis and interpretation, and data-driven decision making.
- Experience in managing technical professionals or CRO in regulated environment.
- Strong leadership, teamwork, writing and communication skills.
- Experience in oncology, hematology strongly preferred
- Comfortable working in a small company environment to execute on a clinical development strategy
- Highly skilled in leading change within an organization
- Strong business acumen (prior interactions with investment community would be an advantage) and critical thinking skills
- Lead the clinical review of clinical and laboratory data, including adverse events, efficacy and correlative science, data query generation and resolution
- Experience managing budget across multiple teams
- Experience developing SOPs and business practice documents
- Willing to travel if required