Pfizer Toxicology Regulatory Strategy Lead in Cambridge, Massachusetts

Our role can be based in Cambridge, MA or at our office in La Jolla, CA. Relocation benefits will be offered to qualified candidate.

Job Summary

The job is for a regulatory Toxicologist. They will be part of the Regulatory Strategy and Compliance (RSC) group within the toxicology (Drug Safety R&D) group in Worldwide R&D (WRD). This person reports into the global regulatory strategy lead in RSC. The primary function of the role is to be the nonclinical safety regulatory expert to project teams and serves as the lead author for nonclinical toxicology contributions to nonclinical submissions components within Pfizer. The role works with other professional within RSC to create and make submission ready e-CTD components of major submissions (eg., IND, NDA, BLA) as well as any other form of document used to communication to global health authorities (IB, PIP, DSURs, CAC, query responses and briefing documents).

The role works closely with toxicology project team leads (DSRD team lead [DSTL]) to provide full support to WRD project teams. The person may also serve as a DSTL on some projects carrying both roles (DSTL and RSL). The person also works with regulatory colleagues in other functional lines in WRD such as Pharmacology, Pharmacokinetics and drug metabolism, clinical, worldwide safety and regulatory to complete submissions.

The role supports the entire Pfizer WRD portfolio but expertise in biologics, gene therapy and vaccine drug development will be a key focus of this role to support those therapeutic areas and provide expert nonclinical toxicology regulatory counsel to DSRD and project team colleagues.

ROLE RESPONSIBILITIES

  • Provide nonclinical toxicology regulatory science advice and consult to DSRD team lead and DSRD Therapeutic area leads

  • Lead author of all nonclinical toxicology components of any submission to global health authorities

  • Coach/mentor more junior colleagues to support this role in future submissions

  • Lead or be active member of Pfizer WRD or DSRD teams optimizing submission requirements/processes

  • Lead external industry consortium/scientific efforts to optimize submission requirements and processes

BASIC QUALIFICATIONS

  • PhD in toxicology or related science or DVM

  • 7 years drug development experience including nonclinical toxicology regulatory submission authorship

  • Strong scientific knowledge in toxicology and risk management

  • Excellent English writing and verbal skills

  • Able to handle multiple projects from many therapeutic areas as part of workload

PREFERRED QUALIFICATIONS

  • Experience in development of biologics, vaccines or gene therapy products

PHYSICAL/MENTAL REQUIREMENTS

Work involves sitting/standing at a desk using a computer

Some travel required

Ability to work effectively on teams

Abel to work in Word, Excel, PowerPoint

Able to effectively manage safety issues for benefit: risk assessments

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional business travel domestic and abroad

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.

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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.