Director/Sr. Director of Safety Operations

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 aiming to address various mechanisms of immune resistance, including myeloid targets. As we advance our pipeline, we are looking for a Director/Sr. Director of Safety Operations to oversee the day-to-day operations of the Drug Safety and Pharmacovigilance department

The Director/Sr Director of Safety Operations will use advanced knowledge of Drug Safety and Pharmacovigilance to provide leadership relating to safety operations, risk management, maintenance of the safety database, management of adverse event cases, oversight of CROs and support of cross functional teams for all clinical trials.

  • Management of drugs safety operations in keeping with regulatory standards
  • Provides strategic planning, audit-readiness, implementation, and management of drug safely operations to support clinical trials
  • Subject matter expert and medical resource for safety operations
  • Review and manage SAE/SUSAR regulatory reporting activities including the processing of SAE reports and review of narratives
  • Collaborate with alliance partners and manage the safety operations aspects of pharmacovigilance agreements such as the exchange of safety data and safety monitoring in clinical trials
  • Contribute to the development of regulatory document such as PSURs, IND annual safety reports and other safety related documents. Also lead the
  • Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities

Job Requirements

  • Advanced degree in a health-related field with at least 6 years of experience in drug safety operations, experience with oncology clinical trials is an advantage
  • An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required
  • Expertise with oversight and management of an electronic safety database for filing, monitoring and tracking serious adverse events
  • Expertise with coding MedDRA and WHODrug
  • Prior global regulatory filing experience such as NDA/BLA, prior MAA is an advantage
  • Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
  • Demonstrated self-starter and team player with strong interpersonal skills
  • Strong computer skills with a proficiency in various software applications (e.g. Microsoft Project, Word, Excel, Visio, PowerPoint)
  • Experience in managing technical professionals or CRO in regulated environment
  • Strong business acumen and critical thinking skills
  • Experience managing budget across multiple teams
  • Experience developing SOPs and business practice documents
  • Strong leadership, teamwork, and communication skills
  • Willing to travel if required
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