This job has expired

You will need to login before you can apply for a job.

Drug Safety Team Lead/Regulatory Toxicology Lead

Cambridge, MA
Start date
Aug 10, 2022

View more

You need to sign in or create an account to save a job.

Job Details


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




  • 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.

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



Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit and connect with us.



Find Us
(212) 733-2323
235 East 42nd Street
New York, NY 10017
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert