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Associate Director, Diagnostics

Pearl River, New York
Closing date
Jul 7, 2023

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Health Sciences, Diagnostics
Position Type
Full Time
Job Type
Organization Type

This is a leadership position in the High-throughput Clinical Immunoassays & Diagnostics' (HCID's) Diagnostics group within Pfizer Vaccine Research and Development (VRD). The position reports to the head of Diagnostics, HCID and will oversee all validation activities related to diagnostics assays used in Pfizer's vaccine clinical trials. This may include both PCR-based molecular diagnostic assays and antibody-based immuno-diagnostic assays. This leadership role will work closely with cross-functional teams (e.g., Assay Development, Statistics, Clinical Research) to ensure diagnostic assay methods are successfully validated in a timely manner to support vaccine clinical studies and advance Pfizer's vaccine portfolio.

Role Responsibilities:
  • Collaborate with Assay Development to successfully transfer diagnostic assays to HCID.
  • Design validation plans and write validation protocols
  • Oversee execution of validation experiments, QC of data, and statistical analyses
  • Write validation reports and address interactions with regulatory agencies on validation queries
  • Collaborate with cross-functional teams to shape overall diagnostic assay clinical testing strategy supporting the vaccine development pipeline
  • Contribute to the selection of commercial assay partners and manage interactions with the vendors supporting clinical studies
  • Support ongoing clinical testing, including troubleshooting technical issues and addressing queries from regulatory agencies
  • Work closely with cross-functional groups to evaluate and improve assay testing throughput
  • Stay current on diagnostic assay techniques and platforms. Advise management on new approaches and technology
  • Provide training to develop assay experts in testing groups

  • PhD with 10+ years of relevant industry experience
  • Demonstrated experience in molecular diagnostic assay development and validation
  • Experience with antibody-based diagnostic assay is a plus
  • Experience with authoring SOPs and assay validation plans/reports
  • Strong communication and interpersonal skills with demonstrated ability to drive, manage and deliver results in cross-functional projects

  • Knowledge and experience with antibody-based immune-diagnostic assays
  • Experience with automating testing workflows and use of laboratory automation systems
  • Training in a GCLP environment and regulatory guidelines

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.


Ability to perform work while standing/sitting.


This position may require occasional weekend and evening work to meet critical business timelines.

This position may require occasional travel between Pfizer sites and other business-related travel.

Other Job Details:

Eligible for relocation package

Eligible for employee referral bonus


Relocation assistance may be available based on business needs and/or eligibility.

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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