The General Toxicology Study Director is responsible for protocol development, design, conduct, data interpretation and reporting of exploratory, mechanistic and GLP in vivo toxicology studies. In addition, the General Toxicology Study Director may provide management of DSRD Outsourced studies, including protocol development , monitoring, study conduct and adherence to the protocol and Pfizer expectations, appropriately communicating and reviewing study updates, reviewing and approving of reports, and partnering with DSRD Team Leads (DSTL) and/or other team representatives to monitor project related milestones.

Responsibilities- Study Director

Responsible for overall technical conduct of in vivo toxicology studies, as well as for the overall interpretation of the studies as described in 21 CFR 58.33., while ensuring compliance with applicable SOPs and guidelines, and Animal Use Protocols.

Responsible for communicating with the DSTL to understand study design, including variation from standardized protocol outlines.

Decision-making responsibilities include:

Final call on interpretation of study findings including overall study conclusion

Major modification to study design (eg, discontinuation, dose changes, etc.)

Handling study deviations and amendments

Responsible for dose selection in conjunction with the DSTL

Other responsibilities may include acting as Principal Investigator for animal use protocols, participating on or leading cross site teams, developing new models and methods, authoring guidelines, formal or informal mentoring of junior colleagues, and/or data collection systems updates and implementation processes.

Responsibilities Associated with External Studies

Responsible for oversight of all phases of outsourced studies (study enabling, study setup, in-life, and reporting). Responsible for partnering with DSTLs and subject matter experts to ensure study milestones are appropriately timed and meet necessary scientific and regulatory requirements. Responsible for participating in on-site monitoring of study activities at CRO sites and CRO qualifications as needed. Provides input/feedback to General Toxicology Study Management group, Outsourcing Operations, and CRO staff on issue resolution, best practices and opportunities for improving activities and relationships.

Responsible for traveling to CRO sites to monitor study activities (up to 15%-20% of time). Business travel may occur on weekends/holidays.

QUALIFICATIONS

PhD in toxicology, pharmacology, or other appropriate discipline with

2 years relevant professional experience; DVM with postgraduate work in toxicological sciences with

2 years relevant professional experience, or MS with at least 3-6 years pharmaceutical industry experience in the design, conduct, direction, or monitoring of toxicology studies.

Demonstrated ability to:

• Work collaboratively in a matrixed, multi-line environment.
• Develop and manage plans to achieve objectives; forecasts and plans resource requirements (people, financial and technology) for projects within DSRD.
• Apply technical, functional and industry knowledge to design and independently execute experiments/ projects that shape the strategic direction of one or more projects.

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 providerame, 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.