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Principal Scientist, General Toxicology Study Director
3 months ago
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
Drug Safety Research & Development (DSRD) is a global organization that provides input into drug target selection, helps identify promising drug candidates, discovers and develops biomarker and screening assays, and leads the conduct and interpretation of toxicology studies in support of clinical development programs and registration. Within DSRD, General Toxicology executes general and specialized in vivo toxicology study strategies to aid in compound selection and enable clinical development across all phases for all therapeutic areas and modalities, derisk and manage issues, and communicate key information to support decision making in the drug development process.
The General Toxicology Study Director is responsible for protocol development, design, conduct, data interpretation and reporting of exploratory, mechanistic and GLP in vivo safety studies, either conducted internally or by managing the conduct of studies externally. This role may also serve as liaison to therapeutic area leadership teams and/or serve on multidisciplinary project teams. All regulatory responsibilities are performed in compliance with applicable regulatory standards.
How You Will Achieve It
Being responsible for overall conduct of in vivo toxicity studies, as well as the overall interpretation of the studies as described in 21 CFR 58.33., while ensuring compliance with applicable SOPs, guidelines, and Animal Use Protocols.
Communicating with Drug Safety Team Leads (DSTLs) to understand study design and any possible variations from standardized protocols, including dose selection in conjunction with the DSTL and Study Director Management.
Making final decisions on interpretation of study findings including overall study conclusions; major modifications to study design, study deviations/amendments/responses to quality assurance audits.
Reporting of studies to agreed timelines and ensuring prompt archival of all study-related materials.
Providing oversight for all phases of outsourced studies eg, study enabling, study setup, inlife, and reporting.
Providing subject matter expertise, scientific training, oversight and/or mentoring to other Study Directors, investigative teams, and/or laboratory personnel
Developing strategic plans for the laboratory, identification of new methods and technologies, development/monitoring of strategic alliance projects with external investigators
Qualifications
Must-Have
B.S. Biological Sciences with more than 12 years relevant experience, M.S. Biological Sciences with 7-10 years relevant experience or PhD Biological Sciences with 3-5 years of experience in relevant specialty area
Advanced knowledge of physiological and pharmacological principles of neuroscience including in vivo / in vitro models for assessment of neurological function or safety assessment.
Strong interpersonal and communication skills with experience working in or leading multidisciplinary teams
Ability to work independently to achieve objectives, and collaboratively in a team-oriented environment under timeline commitments, often necessitating workload prioritization
Nice-to-Have
Prior pharmaceutical industry experience working with animal safety studies
Familiarity working under GLP regulations (ie, quality control, archiving, audit interactions, etc)
Experience with scientific computerized systems, as well as Word, Excel, Pristima/PDS or similar applications
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Responsible for traveling to CRO sites to monitor study activities (up to 15%-20% of time). Business travel may occur on weekends/holidays.
Relocation support available
Work Location Assignment:Flexible
The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Research and Development
