Associate Director, Diagnostics Validation, HCID

ROLE SUMMARY

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

BASIC QUALIFICATIONS

• 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

PREFERRED QUALIFICATIONS

• 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.

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform work while standing/sitting.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

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

#LI-PFE

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

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

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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