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Clinical Assay Lead

2+ years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Role Summary
As a Clinical Assay Lead within the Clinical Bioanalytics (CBx) group in Transitional Clinical Sciences, you will play a critical role in supporting clinical strategies throughout drug development and post-marketing activities. Your focus will be on providing scientific and operational oversight to internal and external stakeholders, ensuring the delivery of high-quality, timely, and regulatory-compliant pharmacokinetic (PK) and pharmacodynamic (PD) bioanalytical assays, data, and reports.

Role Responsibilities

  • Serve as a member of the clinical study team and bioanalytical subject matter expert, assisting in the clinical study setup, protocol development, and review, preparing submissions, addressing regulatory queries, and delivering regulatory-compliant data and reports within program timelines.
  • Lead and oversee the lifecycle management of small molecule PK and PD assays from early-stage development to registration. This includes analytical development, method design, validation, data quality review, sample analysis, and reporting to meet evolving program objectives and regulatory expectations.
  • Assist CROs with troubleshooting bioanalytical assays and issue resolution.
  • Act as the key point of contact with external and internal laboratories, supporting the selection, qualification, performance evaluation, and periodic audits of CRO laboratories conducting clinical PK assays.
  • Support clinical trial conduct by developing and reviewing documents and processes such as CRFs, data setup, clinical site lab manuals, sample management, bioanalytical study planning and reporting, budgeting, invoicing, and ensuring compliance with clinical SOPs, policies, and regulatory inspection readiness.
  • Contribute to the development of Best Practices, processes, templates, and policies.
  • Maintain up-to-date knowledge of current and novel chromatographic separation/mass spectrometry-based detection technologies, global regulatory guidances, and industry best practices.

Basic Qualifications

  • Bachelor’s degree with a minimum of 10 years or Master’s/PhD degree with a minimum of 5 years of bioanalytical experience in Pharma or CRO, specializing in PK assay development, validation, and sample analysis using chromatographic/mass spectrometry methodologies.
  • Working knowledge of GxP regulations governing the conduct of clinical trials and regulatory guidances relevant to regulated bioanalysis.
  • Proven ability to think strategically, work in a highly matrixed environment, and manage multiple projects simultaneously.
  • Strong verbal and written communication and presentation skills.

Work Location Assignment: Remote

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.