Associate Director, Translational Toxicology, Preclinical Development
$170,000–$230,000 year
On-siteLexington, Massachusetts, United States
Job Summary
Represent the Preclinical and Clinical Development Sciences team on program teams, coordinating with CMC, Regulatory Affairs, Clinical Operations, and Discovery Sciences. Design preclinical strategies and toxicity studies, overseeing CRO interfaces and bioanalytical integration to ensure on-time delivery of key data. Provide risk assessment and de-risking strategies for discovery programs, leading issue-resolution teams for investigative toxicology. Work with platform discovery and translational medicine to interpret animal models for efficacy and tolerability, while leading early hypothesis-driven investigations into toxicity mechanisms. Offer strategic guidance to project teams and senior management on the impact of toxicology results on clinical and regulatory strategy.
Required Qualifications
- DVM/PhD or PhD in biology, toxicology or related field
- Board certification in toxicology
- 7+ years in preclinical safety assessment of novel therapeutic entities
- Experience with regulatory submissions and responses
- Background in the safety assessment of drugs intended to treat diseases of the hepatic, kidney, muscular and central nervous systems
- Knowledge of GLP compliance and relevant ICH & FDA guidance documents
- Ability to oversee CRO interface, as appropriate, to deliver high quality, cost-effective, and timely safety assessment
- Ability to travel to monitor out-sourced studies
Desired Qualifications
- Board certification in toxicology
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