Director - Genetic Toxicology Expert

Role Summary

Director - Genetic Toxicology Expert. Position can be based in the US (Cambridge, MA or Emeryville, CA). The Preclinical Safety (PCS) department at Novartis BioMedical Research seeks an experienced Genetic Toxicologist to support non-clinical safety assessment across drug discovery, development, and established medicines with regulatory-compliant research. You will collaborate with cross-functional teams to deliver high-quality, compliant genetic toxicology research and ensure regulatory readiness.

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 drug discovery and development project teams, regulatory submissions and due diligences, and life-cycle management of established medicines.
• Develop and implement state-of-the-art innovative 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; actively share and communicate information back to the Genetic Toxicology team.
• Engaging and collaborating 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: Strong knowledge in genetic toxicology.
• Required: Excellent knowledge of the drug development process.
• 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.
• Preferred: Minimum of 15 years of demonstrated experience in regulatory and investigative genetic toxicology.

Education

• PhD, DVM or equivalent