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Role Summary
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.
Qualifications
PhD, DVM or equivalent
Broad knowledge in genetic toxicology
Knowledge of the drug development process
Minimum of 5 years of experience in regulatory genetic toxicology
Experience in health authority interactions
Strong analytical skills and a commitment to scientific excellence.
Excellent communication and team collaboration skills.