PK and Soluble Biomarker Bioanalytical External Study Monitor

GlaxoSmithKline - Collegeville, PA

Full-time - Senior

Collegeville, PA

5,001-10,000 employees

Chemical Manufacturing

About the position

The Principal Scientist role within GSK's Bioanalysis and Biomarkers Platforms (BBP) department is a high-visibility position focused on managing the full life cycle of bioanalytical studies. The successful candidate will serve as a subject matter expert in Pharmacokinetics (PK) and Biomarkers, working closely with internal and external partners to deliver bioanalytical endpoints for clinical studies. This role involves overseeing method development, assay validation, and ensuring compliance with regulatory standards while contributing to the bioanalytical sections of regulatory submission packages worldwide.

Responsibilities

• Contribute to bioanalytical sections in regulatory submission packages worldwide, especially in emerging markets.
• Provide bioanalytical life-cycle support for all phases of clinical trials, particularly late-phase assets.
• Lead bioanalytical projects in line with agreed departmental/project timelines.
• Act as the SME for biopharmaceutical PK and soluble biomarker immunoassays, providing technical supervision in resolving issues related to PK and soluble biomarker assays in clinical development.
• Serve as the primary interface for communication between GSK and CRO staff.
• Work closely with CRO partners to ensure timelines for method transfer, validation, and sample analysis are met, and communicate any delays.
• Evaluate third-party compliance with GLP, GCP, and worldwide regulations in partnership with GSK External QA.
• Collaborate with internal GSK stakeholders to fulfill requested timelines and data/report delivery.
• Review and contribute to clinical study reports and assist with regulatory filings.
• Manage reference standard and internal standard distribution from Bioanalysis and Biomarker Platforms to CROs.

Requirements

• PhD in Biology, Biochemistry, or related discipline with 2 years of pharmaceutical industry bioanalysis experience, or BS in Biology, Biochemistry, or MS in Biology, Biochemistry or related discipline with 3 years of pharmaceutical industry bioanalysis experience, or BS in Biology, Biochemistry, or related discipline with 5 or more years of pharmaceutical industry bioanalysis experience.
• Experience with method development, method validation, and troubleshooting on various modalities.
• Experience in analysis preparation and reporting of clinical biopharmaceutical PK and biomarker data.
• Experience working under GLP and GCLP bioanalysis principles.
• Data interpretation experience both bioanalytically and in secondary outputs such as PK/PD.

Nice-to-haves

• Previous study monitoring experience.
• Experience in mentoring young scientists in a regulated bioanalysis environment.
• Peer recognition in the pharmaceutical industry through publications and presentations at international conferences.
• Experience contributing to bioanalytical sections in regulatory submission packages, especially in emerging markets.
• Experience in study setup and management of regulated studies in Thermo Watson LIMS.
• Experience with tools or software for tracking CRO key performance indices and study/schedule plans.
• Experience in contract negotiations with partners and third parties.
• Excellent communication skills for interfacing with various functional areas.

Benefits

• Comprehensive benefits program including health insurance, retirement plans, and paid time off.