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General Toxicology Study Director Lead

Employer
Pfizer
Location
La Jolla, California, United States;Cambridge, Massachusetts, United States;
Salary
Competitive
Closing date
Jun 26, 2022

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Discipline
Health Sciences, Toxicology
Position Type
Full Time
Job Type
President/CEO/Director/VP
Organization Type
Pharma
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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, Global Toxicology executes general and specialized in vivo toxicology and safety pharmacology 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 Lead is responsible for General Toxicology study management activities globally supporting the people, portfolio, innovation and productivity goals of DSRD and WRD M . This position provide s strong leadership to the global DSRD General Toxicology colleagues encouraging an environment that enables every colleague to fully contribute, models the Pfizer Leadership Behaviors and Values , and embeds a rewarding scientific climate. This position is responsible for enabling and supporting the Global Toxicology busi ne ss model to deliver the WRD M portfolio. The General Toxicology Study Director Lead is responsible for the global management of S tudy D irectors / S tudy M onitors and the review and approval of General Toxicology work including study design, data interpretation, report writing , and study finalization . The General Toxicology Study Director Lead evaluate s current processes and lead s teams to design and implement new procedures to improve quality, capacity , and efficiency for all aspects of General Toxicology studies conducted either internally or at a Contract Research Organization.

All regulatory responsibilities are performed in compliance with applicable regulatory standards.

How You Will Achieve It
      • L eadership and management of the General Toxicology S tudy D irector / S tudy M onitor functions within DSRD
      • D evelop ment of the strategic direction for the General Toxicology group as well as assuring effective implementation and execution of initiatives
      • Professional development, hiring and management of S tudy D irectors / S tudy M onitors
      • Overall quality of Toxicology studies , ensuring compliance with GLP regulations, SOPs and Safety regulations, and timely reporting
      • Review of internal and external draft protocols to ensure scientific integrity and assess resource demand
      • Review of internal and external draft reports to ensure quality, valid interpretation of study results, and appropriate integration of all individual contributor components
      • R eview and redesign of processes used for both internal and external General Toxicology studies; lead teams to implement changes and hold responsible colleagues accountable
      • Serve as an expert consultant in toxicological and pharmacological sciences to other departments as necessary
      • Participate, as needed, as Drug Safety Team Lead (DSTL), maximum 40%
      • Participate, as needed, in global efforts or teams ensuring the quality and continuous improvement of the toxicology product
      • Participate, as needed, on issue management teams
      • Influence the external environment in the Toxicology discipline


      Qualifications

      Must-Have
      • Ph.D. or D.V.M. or equivalent experience with relevant experience in the Pharmaceutical industry
      • Board Certification in Toxicology or Veterinary Pathology highly desirable
      • At least 5 years of experience in a toxicology leadership position in industry


      Nice-to-Have
      • Demonstrated capability in relevant experience
      • Demonstrated ability to work collaboratively, lead, and manage in a matrixed, multi-line environment

      Work Location Assignment: Flexible

      Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

      PHYSICAL/MENTAL REQUIREMENTS

      None

      NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

      None
      Relocation support available

      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
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