Director - Genetic Toxicology Expert

Role Summary

Genetic Toxicology expert responsible for supporting non-clinical safety assessment across drug discovery and development, as well as established medicines. Based in the US (Cambridge, MA or Emeryville, CA) with cross-functional collaboration to ensure high-quality, compliant research in genetic toxicology.

Responsibilities

• Conduct and monitor genetic toxicology studies and interpret data to support drug discovery and development programs spanning all therapeutic 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 state-of-the-art technologies and systems for regulatory and investigative genetic toxicity testing across all 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.
• Stay at the forefront of emerging technologies in genetic toxicology.

Qualifications

• Required: PhD, DVM or equivalent
• Required: Strong knowledge in genetic toxicology
• Required: Excellent knowledge of the drug development process
• Preferred: Minimum of 15 years of demonstrated experience in regulatory and investigative genetic toxicology
• Required: Work experience in pharmaceutical companies or CRO laboratories servicing pharmaceuticals
• Required: Extensive experience in health authority interactions
• Required: Strong data exploration, analytical skills and commitment to scientific excellence
• Required: Exceptional analytical, communication and collaboration skills