Associate Director/Director, Toxicology
Beam Therapeutics
August 25, 2026
Remote friendly (Cambridge, MA)
United States
$185,000 - $260,000 USD yearly
Clinical Research and Development
Responsibilities:
- Work cross-functionally to drive nonclinical safety-related activities from discovery through regulatory filings and to commercialization for various programs.
- Develop and oversee phase-appropriate nonclinical safety strategies and integrated project plans (milestones, timelines, resources, budgets).
- Coordinate interactions with CROs, in collaboration with Nonclinical Development Operations, to ensure delivery of study results and reports aligned with program timelines.
- Serve as subject matter expert for GLP, non-GLP, and safety pharmacology studies supporting development and platform programs.
- Provide toxicology support for regulatory submissions and interactions with health authorities, including authoring nonclinical safety sections of US and international applications and resolving nonclinical safety queries.
- Drive and be accountable for delivery of high-quality safety reports to support clinical plans and regulatory filings in multiple markets.
- Act as toxicology representative in cross-functional internal and external meetings.
Qualifications:
- Ph.D. with 8+ years scientific experience OR MS with 12+ years scientific experience (BS with 15+ years in preclinical toxicology also considered).
- Experience with LNPs and/or gene therapies.
- Ability to create clear, concise presentations for internal/external meetings.
- In-depth understanding of nonclinical safety and regulatory filings.
- Extensive knowledge of relevant FDA and EMEA regulations and processes.
- Proven experience working with CROs for protocol design and study execution.
- Experience working in cross-functional, collaborative teams.
- Ability to operate in an innovative, science-driven environment; delivery-oriented, hands-on, high ethical standards.
- Expected to come onsite 1–3 days per week.
- Work cross-functionally to drive nonclinical safety-related activities from discovery through regulatory filings and to commercialization for various programs.
- Develop and oversee phase-appropriate nonclinical safety strategies and integrated project plans (milestones, timelines, resources, budgets).
- Coordinate interactions with CROs, in collaboration with Nonclinical Development Operations, to ensure delivery of study results and reports aligned with program timelines.
- Serve as subject matter expert for GLP, non-GLP, and safety pharmacology studies supporting development and platform programs.
- Provide toxicology support for regulatory submissions and interactions with health authorities, including authoring nonclinical safety sections of US and international applications and resolving nonclinical safety queries.
- Drive and be accountable for delivery of high-quality safety reports to support clinical plans and regulatory filings in multiple markets.
- Act as toxicology representative in cross-functional internal and external meetings.
Qualifications:
- Ph.D. with 8+ years scientific experience OR MS with 12+ years scientific experience (BS with 15+ years in preclinical toxicology also considered).
- Experience with LNPs and/or gene therapies.
- Ability to create clear, concise presentations for internal/external meetings.
- In-depth understanding of nonclinical safety and regulatory filings.
- Extensive knowledge of relevant FDA and EMEA regulations and processes.
- Proven experience working with CROs for protocol design and study execution.
- Experience working in cross-functional, collaborative teams.
- Ability to operate in an innovative, science-driven environment; delivery-oriented, hands-on, high ethical standards.
- Expected to come onsite 1–3 days per week.