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Salary: USD 170,000 - 230,000 / annual
Wave Life Sciences, a biotechnology company developing RNA medicines to treat rare and prevalent disorders, seeks an Associate Director of Translational Toxicology to join the Preclinical and Clinical Development Sciences (PCDS) team in Lexington, Massachusetts.
You will provide scientific expertise and leadership across the discovery and development portfolio, with primary responsibility for safety assessment of novel therapeutic oligonucleotides. The role requires deep knowledge of safety pharmacology, investigative and regulatory toxicology, and hands-on experience designing and evaluating both exploratory and GLP-compliant toxicology studies.
Key responsibilities include:
- Serve as primary PCDS representative on program teams, coordinating across CMC, Regulatory Affairs, Clinical Operations, and Discovery Sciences
- Design preclinical safety strategies for discovery and development candidate molecules
- Design and oversee toxicity studies, coordinating with contract research organizations (CROs), bioanalytical teams, and DMPK groups
- Interpret animal disease models for efficacy, tolerability, and PK/PD evaluation
- Lead hypothesis-driven investigations into toxicity mechanisms and proactively manage safety liabilities
- Provide strategic guidance to project teams and senior management on toxicology results and regulatory/clinical implications
- Lead cross-functional issue-resolution teams on investigative toxicology matters
- Serve as key member of Preclinical Development Leadership Team with advancement opportunities
- Oversee CRO interfaces to ensure high-quality, cost-effective, timely safety assessments
- Travel as needed to monitor outsourced studies
Required qualifications: DVM/PhD or PhD in biology, toxicology, or related field; 7+ years of preclinical safety assessment experience; expertise in regulatory submissions and responses; background in safety assessment for hepatic, kidney, muscular, and CNS disease programs. Board certification in toxicology is highly desirable.
Essential competencies: GLP compliance and ICH/FDA guidance knowledge; outstanding interpersonal and communication skills; ability to work independently and collaboratively; strong organizational and prioritization abilities; experience managing CRO relationships.
