The Senior Director/Head of Regulatory Toxicology and will report directly to the Head of Preclinical Safety Assessment. This dynamic individual will be responsible for the management of the Regulatory Toxicology Group and will have oversight of all regulated safety programs in addition to the expectation of serving at the individual project team level to support progression of novel therapeutic agents through the drug development process. A strong background in Regulatory Toxicology including extensive knowledge and understanding of Good Laboratory Practices (GLPs), ICH Guidelines, experience interacting with Regulatory Authorities, and authorship of Regulatory Correspondences and Dossiers is required.
- Management and oversight of up to 4 intermediate to senior level regulatory toxicologists
- Oversight of design, conduct, interpretation, and reporting of all regulatory toxicity studies including resulting risk assessments
- Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with discovery toxicologists, and affiliated preclinical and clinical development functions, as necessary
- Coordinate toxicological/preclinical safety evaluations of development candidates locally and internationally with external contract laboratories, consultants, and development partners
- Responsible for lead authorship of pertinent sections of internal and external regulatory documents (IBs, CTXs, INDs, NDAs, RMPs, Expert Reports, etc.)
- Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of any toxicological findings to human safety.
- Build strong scientific collaborations with external groups within both the academic and industrial sectors with the intent of enhancing Vertex’s Preclinical Safety Assessment capabilities.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
- Ph.D. in Toxicology or relevant field; DABT Board certification preferred.
- A minimum of 12 years of experience in the Pharmaceutical Industry with a proven track record of conduct of drug safety assessment studies, demonstrated ability to manage personnel and multiple scientific projects, and make sound scientific interpretations and risk assessments
- Proficient knowledge of general toxicology is required, demonstrated expertise in inhalation toxicology an added bonus
- In depth understanding and working knowledge of regulatory toxicology, GLPs, and US and International Regulatory Guidelines
- Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities
Loading some great jobs for you...