Role Summary
Associate Director, Genetic Toxicology Expert. Based in the US (East Hanover, NJ or Cambridge, MA) or London, United Kingdom. Responsible for leading genetic toxicology activities to support non-clinical safety assessment across drug discovery and development, ensuring regulatory compliant research and collaboration with cross-functional teams.
Responsibilities
- Conduct and monitor genetic toxicology studies and interpret data to support drug discovery and development programs across modalities and disease indications.
- Provide expert opinions on genetic toxicity assessments to support project teams, regulatory submissions and due diligences, and lifecycle management of established medicines.
- Develop and implement innovative technologies and systems for regulatory and investigative genetic toxicity testing across therapeutic areas and modalities.
- Maintain state-of-the-art scientific and regulatory expertise in Genetic Toxicology.
- Lead cross-functional teams; represent the PCS line function on internal and external boards; communicate findings back to the Genetic Toxicology team.
- Engage and collaborate with key internal and external customer partners.
- Ensure compliance with relevant regulatory guidelines and standards.
Qualifications
- Required: PhD, DVM or equivalent
- Required: Broad knowledge in genetic toxicology
- Required: Knowledge of the drug development process
- Required: Minimum of 5 years of experience in regulatory genetic toxicology
- Required: Experience in health authority interactions
- Required: Strong analytical skills and a commitment to scientific excellence
- Required: Excellent communication and team collaboration skills
- Preferred: Strong data exploration and analysis skills
Skills
- Genetic toxicology expertise
- Regulatory science and compliance
- Data interpretation and analytical thinking
- Cross-functional collaboration and leadership
- Regulatory submissions and lifecycle management
Education
- PhD, DVM or equivalent in a relevant field
Additional Requirements
- Experience with health authority interactions
- Willingness to operate across multiple locations (US or UK) per role needs