18 days old

Drug Safety Team Lead, Toxicology

Pfizer
Pearl River, NY 10965
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**ROLE SUMMARY**



In this role, the individual will serve as the Drug Safety, Research and Development representative on multidisciplinary project teams developing vaccines, biologics, 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 role of the DSTL is to coordinate all activities supporting the nonclinical safety strategy in order to achieve project team objectives and goals, and support stage-gate transitions. In this role, the individual 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 hand in hand with various specialty lines (e.g. immunosafety sciences, 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 therapeutic area lead (TAL) to communicate project progress and achieve alignment on timelines, risk management, de-risking strategies, etc. In addition, DSTLs serve as nonclinical safety Subject Matter Experts (SMEs), working in collaboration with Regulatory Strategy Leads on 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.



**ROLE RESPONSIBILITIES**



+ Attend Project Team meetings, develop expertise in project area, and engage on all related aspects of the project e.g., efficacy, druggability, and clinical safety

+ Attain knowledge of the target, awareness of the competition, and knowledge of global regulatory guidelines

+ Prepare DSRD portions for internal documents, and regulatory dossiers (IND/IMPD, NDA/MAA etc) and regulatory query responses in collaboration with regulatory colleagues.

+ Represent DSRD at project-related Regulatory Agency meetings (e.g., pre-IND, EOP-II, Pre- NDA)

+ Ensure that the DSRD TAL, is kept fully apprised of the progress of a project, both in terms of the overall picture (e.g. timelines, risk management, de-risking strategies, issues from other lines) and the details of study results.

+ Issues management - work with TAL and other DSRD experts as appropriate, to develop de-risking strategies for Toxicology issues.

+ DSTLs will be the primary candidates for in-licensing reviews.



**BASIC QUALIFICATIONS**



+ Ph.D or DVM with ideally 1-3 years drug development or biopharmaceutical experience.

+ 1-5 years of experience in basic and applied research and development preferably in pharma and/or mid-size/large biotech



**PREFERRED QUALIFICATIONS**



+ Additional relevant certifications such as DABT, DACVP, etc.



**Other Job Details:**



Last Date to Apply for Job: June 25th, 2021



Additional Location Information: Pearl River, NY; Cambridge, MA



\#LI-PFE



**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
Posted: 2021-05-26 Expires: 2021-06-28
Sponsored by:
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Drug Safety Team Lead, Toxicology

Pfizer
Pearl River, NY 10965

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