Head of Toxicology
Posted on 8/25/2023
Verve Therapeutics

201-500 employees

Cardiovascular disease biotech company
Cambridge, MA, USA
Experience Level
Biology & Biotech
  • DVM or PhD in a relevant field (Pharmacology, Toxicology) with at least 12 years of post-graduate drug development experience
  • Board certification in toxicology is highly desirable
  • Experience in developing and overseeing toxicology programs to support early and later stage drug development is expected
  • Experience with drug development in gene editing, gene or cell therapy is advantageous
  • Experience with creating or directing an overall toxicology strategy for a biotechnology company working with novel therapeutic modalities
  • Ability to oversee and advance development candidates in multiple programs simultaneously
  • Knowledge of relevant ICH & FDA guidance and regulations that are relevant for the strategic planning and conduct of safety studies to support first-in-human (FIH) testing
  • Experience to draw from regulatory guidance and apply to novel modalities where no or limited regulatory guidance exists
  • Demonstrated ability to apply critical thinking to solve complex problems to craft customized preclinical strategies for novel therapeutics
  • Experience in authoring of preclinical safety section in regulatory filings such as INDs/CTAs
  • Ability to critically evaluate written toxicology documents for overall quality and acceptability of scientific interpretation
  • Ability to oversee CRO interface, as appropriate, to deliver high quality, cost-effective, and timely safety assessment
  • Outstanding interpersonal skills and oral and written communication skills
  • Ability to manage a team with remote employees in a hybrid environment
  • Develop and direct a road map for toxicology assessment throughout the drug development life cycle of current and future Verve gene editing therapies
  • Lead the toxicology functional area, manage toxicology goals, priorities, resource requirements, budget, and timelines
  • Provide strategic guidance to project teams and senior management, including evaluation of conclusions and potential impact of toxicology findings on programs
  • Together with the research, regulatory, and clinical teams develop strategies and customized solutions for novel editing modalities
  • Serve as a member of program teams and collaborate with internal and external research partners including preclinical pharmacology, bioanalysis, and translational sciences to advance drug candidates from discovery to the clinic
  • Provide internal expertise to understand the mechanisms of toxicity, propose steps for mitigation and back-up strategies
  • Design and direct nonclinical studies, including the evaluation and interpretation of safety, pharmacology, toxicology, and toxicokinetic information
  • Develop optimal CRO network for toxicology studies, build and maintain effective vendor relationships
  • Oversee the toxicology study monitoring team and serve as study monitor and sponsor representative for outsourced studies as needed
  • Draft, review, and provide feedback on study protocols, reports, and other documentation as needed
  • Communicate toxicology data to stakeholders including nonclinical functional areas, program teams, and executive leadership
  • Author or facilitate authoring of nonclinical summaries for safety pharmacology, biodistribution, and toxicology for submissions to regulatory bodies in US and ROW (e.g., BLAs/MAAs, INDs, IBs and briefing packages)
  • Represent Verve in Regulatory Agency interactions for toxicology-related issues