Dsrd Drug Safety Team Lead

Pfizer Cambridge , MA 02138

Posted 5 months ago

Position Summary

  1. 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 TA (used synonymously with RU) in order to deliver on TA portfolio goals and stage-gate transitions. In addition, DSTLs serve as non-clinical safety Subject Matter Experts (SMEs) in collaboration with Regulatory Strategy Leads (RSLs) on dossier preparation and responses to regulatory queries.
  2. 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, PDM) in order to achieve project team objectives and goals.
  3. DSTLs will assess potential safety concerns associated with a target under consideration by the Research Unit (RU). A key deliverable is a Target Knowledge Review [TKR] for a specific target of interest to the RU. The DSTL is typically the primary author of the safety sections of the TKR, working with the DSRD Disease Area Lead (DAL), the DSRD Therapeutic Area Lead (TAL) and appropriate SMEs in DSRD and Research to provide an integrated assessment of potential safety issues and a proposed target de-risking strategy.
  4. DSTLs will ensure that the DSRD TAL, is kept fully apprised of the progress of a project, both in terms of the overall picture (e.g. timelines, risk management, de-risking strategies, issues from other lines) and the details of study results.
  5. DSTLs serve as the scientific and technical representatives for outsourced studies within their area of expertise for their projects. DSTL will coordinate with STRs for studies outside their area of expertise.
  6. DSTLs will be the primary candidates for in-licensing reviews.
  7. DSTLs will represent DSRD at project-related regulatory agency interactions.

Position Responsibilities

Perform all regulatory responsibilities in compliance with applicable regulatory standards.

Strategic activities of projects:
1.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
2.Attain knowledge of the target, awareness of the competition, and knowledge of global regulatory guidelines
3.Early Project Teams (targets). DSTLs

  • Serve as the DSRD POC for exploratory/target identification and selection activities for an individual target.

  • Work with appropriate SMEs in DSRD and elsewhere to identify potential target safety risks, place them into appropriate context for the indication and proposed patient population, and develop a target de- risking strategy.

  • Interact with DSRD and other SMEs as needed to execute the target safety de-risking studies.

  • Periodically review emergent information and data sets for the target, incorporating new information (internal and external) into the TKR.
    4.Design nonclinical safety strategy and Toxicology Plan for SDS-FIH and FIH-Registration studies in association with DSRD TAL and schedule required studies to meet Project timelines. Coordinate amount and delivery of API with Pharm Sci. Maintain information current in Portfolio Information Management System (PIMS)
    5.Prepare DSRD portions of CAN and similar documents, and regulatory dossiers (IND/IMPD, NDA/MAA etc) and regulatory query responses in collaboration with RSC.
    6.Represent DSRD at project-related Regulatory Agency meetings (e.g., pre-IND, EOP-II, Pre- NDA)
    7.Coordinate FIH decision consensus process (prepare and present Toxicology Review of findings)
    8.Communicate Project status, progress, and potential impediments to DSRD TAL
    9.Issues management work with TAL and other DSRD experts as appropriate, to develop de-risking strategies for Toxicology issues.


  1. Schedule and monitor progress of Toxicology studies, and communicate results to DSRD organization, i.e., TAL and to the Project Team.
  2. Coordinate with other nonclinical dossier contributors (PDM and Pharmacology) to assure timely deliverables to NCO.
  3. Participate in Due Diligence activities as needed (determined by DSRD TAL).
  4. Will include project milestones within their goals and be held accountable for them.

Coordinating tactical activities for studies:
1.Study design (including dose selection), especially identifying compound-specific issues that will need to be addressed in studies.
2.Coordinate with Study Director (SD), details of specific studies and resources.
3.Prepare study request form and review protocol in collaboration with SD, including dose selection and study-specific requirements.
4.Ensure alignment of API delivery in accordance with study timelines.
5.Conduct study design meeting, as appropriate.
6.Monitor study progress and update DSRD TAL, and present study results to Project Team.
7.Serve as the study monitor, i.e. scientific and technical representative for outsourced studies from their projects within their area of expertise. Address issues that arise during the study, interact effectively with the SDs at the CRO; conduct timely review of data during the study to be aware of trends and identify issues/concerns; conduct timely review of the draft report to ensure that conclusions are aligned with data. DSTL will coordinate with STRs for studies outside their area of expertise

Qualifications

  • Ph.D, DVM, or MS with at least 3 years pharmaceutical industry experience.

  • Minimum of 2 years relevant experience depending on project's stage in development

  • Demonstrated ability to work collaboratively in a matrixed, multi-line environment

  • Some experience with Gene Therapy programs desired

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.

Other Job Details:

  • Eligible for Relocation Package: yes

  • Eligible for Employee Referral

    Bonus:
    yes

N (Other) (United States of America)

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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Dsrd Drug Safety Team Lead

Pfizer