# Clinical Assay Lead

**Company**: Pfizer
**Location**: Shanghai, STIT
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/China---Shanghai---STIT/Clinical-Assay-Lead--Manager--Contractor---Shanghai-or-Beijing_4966466?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_02756750-841

## Description

As a Clinical Assay Lead in the Clinical Assay Group within Development China Clinical Pharmacology at Pfizer, you will play a critical role in supporting clinical strategies in all stages of drug development and post-marketing activities.

You will serve as a member of the clinical study team and analytical subject matter expert for executing clinical study setup and conduct, contributing to the study protocol development and review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies and assays, and delivering regulatory compliant data and reports within program timelines.

Key responsibilities include:

- Leading and overseeing small or large molecule PK, PD, and immunogenicity assay and biomarker assay lifecycle management from early stage to registration

- Corresponding sample analyses and reports to meet evolving program objectives and regulatory expectations

- Assisting CROs with effective troubleshooting of the bioanalytical assay and issue resolution

- Supporting the clinical trial conduct within the scope of the Clinical Assay Group responsibilities

- Contributing to the development of Best Practices, processes, templates, and policies

- Maintaining up-to-date knowledge of current and novel chromatographic separation/mass spectrometry-based detection, ligand binding technologies and techniques, or bioanalytical techniques commonly used for Biomarkers

You will have indirect responsibility for the clinical budget allocated to bioanalytical support of the clinical study or program, develop bioanalysis agreements with commercial and academic laboratories, and be responsible for approval of invoices for work overseen.

You will report to the Clinical Assay Group Lead and have frequent interaction with colleagues in Clinical Pharmacology, Clinicians, Contract Research Organizations (CROs), Clinical Operations, Statistics, Regulatory, Finance, and external collaborators.

Specific requirements include hands-on experience with the development, validation, and troubleshooting of methods commonly used for Biomarkers, Biologics, or Small Molecules.

## Skills

### Required
- bioanalytical techniques
- chromatographic separation
- mass spectrometry
- ligand binding technologies
- Biomarkers
- Biologics
- Small Molecules
- GxP regulations
- regulatory guidances

### Nice to have
- CRO management
- outsourcing experience
- regulatory inspections
- regulatory submissions
- training and mentoring

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