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Director/Sr. Director Global Safety and Pharmacovigilance

Company: Compugen Ltd.
Location: San Francisco
Posted on: June 12, 2021

Job Description:

Job Description

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 focused largely on myeloid targets. As we advance our pipeline, we are looking for a candidate with expertise in clinical development safety and pharmacovigilance. The successful candidate is expected to work cross functionally within the company on multiple programs. This position reports to the Chief Medical Officer.

  • Provide leadership and direction for all safety and pharmacovigilance activities
  • Guidance and oversight of CROs and other stakeholders
  • Key job responsibilities: include signal detection, authoring safety management plan, benefit-risk assessment, risk management and mitigation and leading the development of regulatory documents with safety sections such as IB, clinical protocol, DSUR, clinical study reports, SAP, SMP

Job Requirements

  • Advanced degree in the life sciences MD, PhD
  • Three years' experience in the pharmaceutical industry as a safety clinician in hematology, medical oncology, prior experience as a safety physician with immuno-oncology clinical trials- Advantage
  • Prior experience interacting with regulatory authorities, collaborating with and leading cross-functional teams- Advantage
  • Extensive knowledge of global safety reporting guidelines, review and interpretation of safety data in the relevant databases (safety and clinical database) and interpretation of safety data from clinical studies
  • Extensive knowledge of regulatory guidelines (GCP, ICH)
  • Demonstrated track record of success working on cross functional multidisciplinary teams
  • Relevant experience leading or supporting regulatory filing (IND, NDA, BLA), safety-related interactions with regulatory authorities
  • Contribute to safety-related discussions on candidate drugs in the pipeline
  • Excellent writing and communication skill
  • This role requires up to 20% travel

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Keywords: Compugen Ltd., San Francisco , Director/Sr. Director Global Safety and Pharmacovigilance, Other , San Francisco, California

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