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Director, Clinical and Diagnos...

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_4693834

Director, Clinical and Diagnostic Assay Development

About the Job

Role Description

This is a senior position within Pfizer’s Vaccines Research and Development.   The incumbent will manage and oversee a group responsible for the development, qualification and validation of biofunctional assays (OPAs, SBAs, IVPA and viral neutralization assays) for preclinical and clinical development of various vaccine candidates.  The incumbent and his/her group will also take responsibility of evaluating a number of vaccine candidates in small animal and NHP models. The incumbent will have responsibility for monitoring of team performance, assay improvement, and assay troubleshooting that pertain to Pfizer specific vaccine projects. It is the responsibility of the incumbent to prioritize projects, approve assay protocols and reports, and to assure the quality of data generated. This position operates with limited supervision and directs activities of junior and mid-level staff.  All work is to be done in a compliant manner according to relevant SOP guidelines and cGLP/cGMP guidelines, when required.  The position is located in Pearl River, NY, and reports to the Executive Director for Clinical & Diagnostic Assay Development.

Responsibilities

  • Oversee the development, qualification and validation of various bio-functional assays to support both preclinical toxiciology and clinical testing.
  • Manage the development of in vivo potency assays and evaluation of novel adjuvants in animal models.
  • Provide scientific leadership, strong interpersonal and coaching skills through team roles and mentoring of scientists.
  • Act as the assay lead in the support of various vaccine programs.
  • Act as the representative of Pfizer’s Vaccine Research and Development to attend different scientific or regulatory related meetings.
  • Satisfactorily completes all GLP and safety training conforming to Pfizer & Departmental requirements. Where applicable, performs job responsibilities in compliance with GLP and all other regulatory agency requirements.
  • Complete other jobs as assigned.

Basic Qualifications

  • PhD in Immunology or related field
  • Minimum 10 years of post-graduate experience (preferably in industry but not required)
  • Expertise in the development, qualification and validation of clinical bioassays such as OPAs, SBAs, cell-based neutralization assays and in vivo potency assays
  • Knowledge of current ICH, USP and FDA guidance’s on assay validation is required.
  • Possess sufficient statistical knowledge to facilitate interactions with staff statisticians.
  • Experience in managing junior and senior scientists
  • Strong verbal and written communication skills
  • Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software

Preferred Qualifications

  • Industry experience

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:

  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus

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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