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Director of Safety Assessment

Cambridge, MA

Company Overview:

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.  

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com.

Position Overview

Join our collaborative, agile and fast-paced Liver Programs & Development Sciences team to develop Prime Editors that could help patients in rare diseases and beyond.

Reporting to the Vice President, Liver Programs & Development Sciences, the successful candidate will be responsible for leading the strategic oversight of all safety (GLP and non-GLP) and tolerability studies in rodents, NHP and other appropriate animal models, to be conducted either internally and/or at external contract research laboratories within the US and internationally. The ideal candidate must exhibit exceptional functional expertise, collaborative behavior and be comfortable to excel in cross-functional matrixed project team environments, deliver results in a timely manner and have excellent communication skills to effectively communicate to managers, project teams and leaders in the organization.

Responsibilities

  • Toxicology strategy and sub-team leadership
    • Develop and own the global toxicology strategy for portfolio programs from discovery through IND/NDA submissions
    • Provide expert analysis on nonclinical safety findings, offering actionable guidance to cross-functional teams (Discovery, DMPK, Clinical, Pharmacovigilance)
  • Study Design, Execution & Oversight
    • Lead the design and oversight of GLP and non-GLP toxicology studies, including general, genetic, germline transmission, reproductive, carcinogenicity, safety pharmacology, and toxicokinetics
    • Manage CRO relationships from selection to monitoring to ensure scientific rigor, timelines, budgets, and regulatory compliance
  • Cross-functional Influence & External Collaboration
    • Act as subject-matter expert across project teams, guiding risk assessment strategy and decision-making
    • Collaborate with pharmacology and research team to select predictive models and explore mechanisms of toxicity in the process of lead optimization and development candidate selection
    • Lead IND-enabling studies and effort to establish NOAEL and TI. Collaborate with Clinical to support the translation from nonclinical to clinical testing.
    • Collaborate with TDO to support the establishment of safe and well characterized products, bridge nonclinical and clinical materials, evaluate excipient and novel component safety and manage risk from process impurities
  • Regulatory Submissions & Documentation
    • Collaborate with Regulatory by authoring and reviewing nonclinical sections of regulatory submissions: INDs, CTAs, IBs, BLAs, NDAs, NDAs/MAAs, and responses to health authority inquiries
    • Collaborate and support Research, Clinical and TDO in respective sections in regulatory document where safety and toxicity are tightly connected among studies conducted in different line functions
    • Serve as company’s nonclinical toxicology representative in meetings with regulators (FDA, EMA, ICH)

Qualifications:

  • PhD in Toxicology, Pharmacology, or related field (DABT certification preferred)
  • 10-12+ years of industry experience in pharmaceutical/biotech toxicology
  • Expert knowledge of toxicology disciplines: general, developmental/reproductive, safety pharmacology, carcinogenicity, toxicokinetics
  • Demonstrated track record managing GLP studies, CRO relationships, and regulatory submissions across lifecycle stages
  • Excellent scientific writing skills for regulatory and clinical documents; strong oral communication for both internal and external engagements
  • Deep familiarity with GLP regulations, FDA/EMA/ICH guidelines, and health authority interactions
  • Proven ability to lead cross-functional teams under tight timelines in a dynamic biotech or pharma environment.
  • Strong interpersonal and organizational skills, with a high degree of attention to detail.
  • Ability to deal with competing priorities, strong reasoning, detail oriented and creative problem-solving ability is essential
  • “Do-what-it-takes” approach to problem solving and prospective thinking.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
  • Independently motivated, detail oriented and good problem-solving ability.
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
  • Positive, outgoing and collaborative attitude with a passion for helping patients using innovative science
  • Be ready to embrace the principles of the Prime culture

Preferred Experience

  • Experience in genomic medicine (gene transfer and/or gene editing) drug development
  • History of published work and presentations at scientific conferences
  • Experience evaluating assets for in-licensing or business development due diligence
  • Experience with in silico or translational toxicity screening models.

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.

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