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Drug Safety Team Lead

Monster
 
 
 
 

Job Summary

Company
Pfizer
Location
Pearl River, NY
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4903_4703825

Drug Safety Team Lead

About the Job

Drug Safety Team Leads (DSTLs) are responsible for developing, and implementing the nonclinical safety strategy for projects from Idea to Loss of Exclusivity (LoE). Safety strategies will be aligned with overall objectives of the RU in order to deliver on RU portfolio goals and stage-gate transitions. In addition, DSTLs serve as nonclinical safety Subject Matter Experts (SMEs) in collaboration with Regulatory Strategy Leads (RSLs) on dossier preparation and responses to regulatory queries. DSTLs will represent DSRD on multidisciplinary project teams and will work to coordinate nonclinical safety strategies with activities of other lines (e.g. Pharm Sci, BMD) in order to achieve project team objectives and goals.

The job is for a Drug Safety Team Lead (DSTL).  They will be part of the Portfolio group within the toxicology (Drug Safety R&D) group in Worldwide R&D (WRD) in Pearl River, NY.  They will support the Oncology Research Unit and the Vaccine Research Unit. This person reports into the therapeutic area lead for oncology in the portfolio group.  The primary function of the role is to be a full-time DSTL representing DSRD on drug discovery and development teams.  DSTLs are responsible for developing, and implementing the nonclinical safety strategy for projects from Idea to Loss of Exclusivity (LoE). Safety strategies will be aligned with overall objectives of the RU in order to deliver on RU portfolio goals and stage-gate transitions. In addition, DSTLs work with Subject Matter Experts (SMEs) and in collaboration with Regulatory Strategy Leads (RSLs) on dossier preparation and responses to regulatory queries. DSTLs will represent DSRD on multidisciplinary project teams and will work to coordinate nonclinical safety strategies with activities of other lines (e.g. Pharmacology, Clinical, Pharm Sci) in order to achieve project team objectives and goals.  A minimum of 7 years drug development experience at a pharmaceutical or biotechnology company is recommended.  This experience should be as part of a drug development team supporting toxicology safety assessments.

ROLE RESPONSIBILITIES

  • Design safety strategy for therapeutic or prophylactic vaccines, and novel oncology biotherapeutics.
  • Attend Project Team meetings, develop expertise in project area, and engage on all related aspects of the project e.g., efficacy, druggability, and clinical safety.
  • Prepare DSRD portions of  project stage-gate documents and collaborate with regulatory strategy leads in regulatory dossier preparation.
  • Represent DSRD at project-related regulatory agency meetings.
  • Coordinate FIH decision consensus process.
  • Design, schedule, and monitor progress of Toxicology studies, and communicate results to DSRD organization and the Project Team.
  • Coordinate tactical activities for Toxicology studies.
  • Coordinate with other nonclinical dossier contributors to assure timely deliverables to regulatory dossiers.
  • Participate in Due Diligence activities as needed.

QUALIFICATIONS

  • PhD  in toxicology or related science or DVM
  • Strong immunology background
  • 7 years drug development experience as part of a drug development project team
  • Strong technical knowledge and ability in various aspects of  toxicology.
  • Excellent oral and written communication skills, and organizational skills.
  • Familiarity with nonclinical regulatory guidelines.
  • Ability to effectively coordinate activities across sites.
  • Willingness to apply novel techniques and strategies in safety evaluation.

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.

Other Job Details:

  • Last Date to Apply for Job: August 15, 2018

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

 

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