Director of Genetic Toxicology-PRE000311
This position entails managing a genetic toxicology group that supports all aspects of drug development.
Responsibilities include but are not limited to:
Working with drug discovery scientists to help select non genotoxic molecules and metabolites, by understanding the chemical structures and by designing appropriate genotoxicity screening strategies
Overseeing genetic toxicology testing in support of regulatory filings
Collaborating with chemists in drug synthesis design and analytical sciences for proactive control of potentially mutagenic impurities
Collaborating with toxicologists and regulatory staff to develop strategies to resolve regulatory and safety issues related to genetox in drug development, at all stages from early clinical development through mature products, including impurities/degradates.
Collaborating with investigative toxicology groups to incorporate DNA damage and genetic toxicology endpoints into early safety screening. Assessing new test methods and screening strategies
Education Minimum Requirement:
Advanced degree in biological/biochemical sciences, with a minimum of 6 years post-doctoral experience.
Required Experience and Skills:
Broad knowledge and hands-on experience both in fundamental genetic toxicology, and in understanding of regulatory guidelines.
Recognition for their expertise in the genetic toxicology field, with appropriate publication record and participation in collaborative projects across organizations.
Extensive experience in carrying out genetic toxicology testing to support regulatory filings, and to support selecting and development of new drug candidates.
In depth experience in problem solving related to regulatory issues and to drug discovery genetox strategies in the pharmaceutical industry.
Expertise in chemistry of structure-activity-relationships for mutagenic potential and understanding of drug metabolism is necessary to contribute to providing advice to drug discovery programs, to Process Chemistry for control of impurities, and to occupational health testing.
Excellent communication and collaboration skills
Preferred Experience and Skills -
Experience in managing a group.
Knowledge of chemical carcinogenesis. Experience in toxicology and drug development an advantage for potential opportunities in managing drug development projects
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # PRE000311. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
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