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.
- 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.
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
Relocation assistance may be available based on business needs and/or eligibility.Sunshine Act
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Research and Development