Director of Toxicology & Safety Assessment
Sci.bio Recruitinga year ago
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OnsiteFull-timeDirector
Summary
Sci.bio Recruiting is seeking a Director of Toxicology & Safety Assessment to join their team in Cambridge, MA. The role involves leading the strategic oversight of safety and tolerability studies in various animal models.
About the Role
As the Director of Toxicology & Safety Assessment, you will be responsible for developing and owning the global toxicology strategy for portfolio programs, leading the design and oversight of GLP and non-GLP toxicology studies, managing CRO relationships, and collaborating with cross-functional teams to guide risk assessment strategies. You will also author and review nonclinical sections of regulatory submissions and represent the company in meetings with regulators.
About You
Required:
- 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.
Preferred:
- 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.
Sci.bio Recruiting
Sci.bio offers transformative recruiting solutions for biotechnology & pharmaceutical companies and life science organizations Our integrated model can provide RPO & Contract Recruitment, Boutique Executive Search and Contract Staffing support. We utilize a flexible, value oriented approach and our experienced team has a long track record of success with numerous client success stories to highlight. Let us partner with you and help grow your life science organization.
Cambridge, MA