This position is in Drug Safety Research and Development (DSRD), the nonclinical toxicology group within Pfizer Worldwide R&D. Project regulatory toxicologists (Drug Safety Team Leads [DSTLs]/ Regulatory Toxicology Leads [RTLs]) are in the Portfolio and Regulatory Strategy (PRS) line within DSRD and are the nonclinical regulatory experts. This DSTL/RTL will have broad drug development experience with the responsibility to develop the scientific and strategic message for high quality nonclinical safety packages. Thus, the candidate is expected to have a solid grasp of national and global nonclinical regulatory guidelines and strong regulatory writing and verbal skills. In addition, the candidate will be involved in developing and implementing strategies to influence the internal and external (health authorities) nonclinical regulatory environment. Candidates will be involved in internal and external working groups and consortia including working with organizations such as PhRMA, DruSafe and/or BioSafe to influence the nonclinical safety and regulatory environment. Individuals may be assigned to due diligence teams to assess potential acquisition or licensing candidates and work with internal experts to manage safety aspects of product quality issues. The candidate will support all therapeutic areas and both small and large molecule modalities.
Provide nonclinical scientific and regulatory strategy leadership and input on cross-line matrixed project teams from pre-FIH through LOE
Lead author of all nonclinical toxicology components of any submission to global health authorities.
Contribute to ensuring compliance of dossiers to global health authority standards and work closely with regulatory submission scientists and document specialists in the PRS line.
Coach/mentor more junior colleagues to eventually take on this role independently.
Lead external industry consortium/scientific efforts to optimize nonclinical safety strategy and submission requirements.
Participate in Due Diligence activities as needed.
Advanced degree such as a PhD, MD, or DVM and expertise in Toxicology, Pathology or allied biological sciences
Experience level should be a minimum of 10 years of nonclinical aspects of pharmaceutical drug development, spanning early stage to post market scientific and regulatory strategy and submissions.
Expectations include a working knowledge of international regulatory guidelines and practices, demonstrated ability to develop strategies and author regulatory documents of high quality, appropriate decision-making regarding candidate development and regulatory submissions, ability to communicate verbally and in written context well across business lines, and effective leadership of teams of diverse expertise
Specific working knowledge of nonclinical safety requirements across a broad range of therapeutic areas and modalities, including but not limited to gene therapies
Hands on experience in design, conduct, and interpretation of nonclinical toxicology studies
Ability to formulate a concise summary of complex safety (toxicology, pharmacokinetics and biology) data from multiple sources
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Additional Location Information: Groton, CT and Pearl River, NY
Eligible for Relocation Package: YES
Eligible for Employee Referral Bonus: YES
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Research and Development