• Biologics Expert , Non-Clinical Regulatory Toxicology Jobs in United States Of America

  • Pfizer Inc.
  • United States Of America, Usa
  • Save Job
  • 15 - 18 Years
  • Posted : above 1 month

Job Description:

Pfizers Biopharmaceutical division is a world leader in Biologic therapies with over 50 PERCENT of its innovative portfolio made of Biologics encompassing a variety of modalities, including monoclonal antibodies and related molecules, gene therapy, and vaccines across several therapeutic areas With this increased focus on Biologics, Pfizers Non-Clinical Regulatory Strategy group in the Drug Safety Research and Development (DSRD) organization is seeking to recruit a World Expert in the nonclinical safety of Biologic modalities to be part of a larger team of regulatory Toxicology experts The successful candidate for this senior position will

Be recognized nationally and internationally as a nonclinical Biologics expert, with a strong regulatory background and track record of influencing the external environment
Have a track record of leading/representing industry consortium/trade associations
Have significant experience of developing the nonclinical safety strategies for a range of Biologics modalities
Posses the ability to shape Pfizers nonclinical safety strategy for the Biologics of the future
Have a track record of mentoring colleagues in Biologics safety science
Have an ability to support nonclinical regulatory submissions/filings

This successful candidate will also be expected to spend a portion of their time acting as a Drug Safety Team Lead, representing DSRD on project teams, and supporting due diligence activities for potential acquisition/licensing candidates Furthermore, she/he may represent DSRD on internal safety advisory committees

ROLE RESPONSIBILITIES

Provide nonclinical toxicology regulatory science advice and consult to DSRD team lead and DSRD Therapeutic area leads
Lead author of all nonclinical toxicology components of any submission to global health authorities
Coach/mentor more junior colleagues to support this role in future submissions
Lead or be active member of Pfizer WRD or DSRD teams optimizing submission requirements/processes
Lead external industry consortium/scientific efforts to optimize submission requirements and processes

BASIC QUALIFICATIONS

PhD in toxicology or related science or DVM
Minimum 15 years drug development experience including nonclinical toxicology Biologics regulatory submission authorship
Subject Matter Expert in Biologics, Toxicology and Risk Management
Excellent English writing and verbal skills
Able to handle multiple projects from many therapeutic areas as part of workload

PREFERRED QUALIFICATIONS

Experience in development of Biologics, vaccines or gene therapy products

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 providers 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

Additional Location Information La Jolla, CA; Cambridge, MA; Groton, CT; Pearl River, NY
Eligible for Relocation Package
Eligible for Employee Referral Bonus

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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : HR/PM/IR/Training
Role : Recruitment
Salary : As per Industry Standards
Deadline : 23rd Jan 2020

Key Skills:

Company Profile:

Company
Pfizer Incarfix

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