Why Patients Need You
Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world. What You Will Achieve
Pfizer's Portfolio and Regulatory Strategy (PRS) is a highly innovative, functional and integrated scientific discipline contributing to the advancement of the overall portfolio. In this position within PRS in Drug Safety Research and Development (DSRD), you will serve as the Drug Safety Team Lead (DSTL) as DSRD representative on multidisciplinary project teams developing biologics, vaccines, gene therapies, and/or small molecule drugs.
The DSTL is responsible for developing and implementing the nonclinical safety strategy for projects from Idea to Loss of Exclusivity (LoE). The DSTL coordinates all activities supporting the nonclinical safety strategy to achieve project team objectives and goals, and support stage-gate transitions. In this role, you would identify potential toxicities as well as create strategies to either mitigate or monitor these risks in the clinic. Within Drug Safety, Research and Development, the DSTL will work with various specialty lines (eg, immunotoxicology, pathology, investigative toxicology, general toxicology, etc...) to ensure that all supportive studies and potential safety risks are fully understood.
The DSTL works closely with the Drug Safety Therapeutic Area Leader (TAL) to communicate project progress and achieve alignment on timelines, risk management, mitigation strategies, etc. In addition, DSTLs serve as nonclinical safety Subject Matter Experts (SMEs) working in collaboration with Regulatory Toxicology Leads (RTLs) on global regulatory submissions and responses to regulatory queries. The DSTL will represent DSRD at project-related regulatory interactions, support in-licensing reviews, and may take on additional roles depending on their qualifications. How You Will Achieve It
Provide nonclinical scientific and regulatory strategy leadership and input on crossline matrixed project teams from pre-FIH through LoE.
Represent DSRD at project-related regulatory interactions.
Participate in Due Diligence activities as needed.
Communicate toxicology findings in both oral and written formats to all levels of the organization and through external publications.
Advanced degree such as a MSc or PhD and expertise in Toxicology or allied biological sciences
3-5 years of experience in nonclinical aspects of pharmaceutical drug development, spanning early stage to post market scientific strategy and submissions.
Expectations include a working knowledge of international regulatory guidelines and practices, demonstrated ability to develop strategies of high quality, appropriate decision-making regarding candidate development, 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
Hands on experience in design, conduct, and interpretation of nonclinical toxicology studies
Demonstrated ability to author regulatory documents of high quality
Ability to formulate a concise summary of complex safety (Toxicology, Pathology, pharmacokinetics and biology) data from multiple sources NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Relocation support available
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.
\nPfizer 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.Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. 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