Manager, Biomarkers and Bioanalytical Operations

AboutThisRole:

The Biomarker and Bioanalytical Operations Study ManagerleadsPK, ADA, and biomarker execution across clinical studies, partnering with study teams and CROs to deliver high-quality data on time. This role is critical to achieving key study endpoints and advancing programs through drug development and reports tothe Head of Biomarker and Bioanalytical Operations. 

WhatYou’llDo

• Serve as the primary Biomarker and Bioanalytical Operations lead for internal teams and external partners across Phase 1–4 studies

• Lead end-to-end operational execution of biomarker and bioanalytical activities, including sample collection, processing, shipment, testing, storage, and data delivery

• Implement clinical biomarker and bioanalytical strategies for early- and late-stage programs

• Provide operational and sample managementexpertiseto Study Management Teams (SMTs) and Biomarker Sub-Teams (BMSTs)

• Ensure compliant, high-qualitybiomarker and bioanalytical samplecollection aligned with protocols, ICFs, ethical standards, and regulations

• Oversee CROs, central labs, and specialty vendors; manage performance, timelines, quality, contracts, and deliverables

• Review and contribute operational input to protocols, CRFs, ICFs, proposals, budgets, study plans, and contracts

• Develop study-specificbiomarker and bioanalytical samplecollection, handling, analysis, transport, and storage strategies

• Partner cross-functionally (Clinical Biomarker, Clinical Pharmacology, Clinical Operations, Data Management, Business Operations& Contracts Partner) to enable efficient executionof the study

• Define data collection, transfer, and reconciliation requirements with data management, bioanalytical leads, and vendors

• Identifyoperational risks, implement mitigation plans, and support interim and final biomarkerand bioanalyticalreporting

• Lead operational meetings, RFPs, vendor selection, and process improvement initiatives

• Maintain biomarker operations systems and documentation; represent on cross-functional teams

• Operate independently with general supervision; support investigator meetings and internal/external presentations as needed

Who You Are 

You excel in fast-paced clinical development environments dedicated to advancing new therapies to patients. Yourexpertisein scientific operations, GCLP, and CRO management enables effective collaboration across internal teams and external laboratory partners.

Required Skills 

Minimum Education & Experience

• Advanced degree (PharmD or PhD) with 2+ years of relevant industry experience; MA or MS with 6+ years; or BA/BS or RN with 8+ years of comparable clinical, life sciences, or similar industry experience.

• Good knowledge of phase I-IVclinical study operations as it pertains to specialty testing (PK, ADA, Biomarkers) 

• Experience working with contracted central labs and biomarker/bioanalytical testing labs including sample management, data management, testing requirements and timelines 

• Experience reviewing clinical protocols,ICFs, SOW,and contracts

• Experience obtaining contracts and an understanding of Master Agreements and associated contracts 

• Experience working within GCP, GLP, & GCLP guidelines  

• Must be very organized and have the ability to manage multiple projects at a time  

Preferred Skills

• Demonstrated ownership of operational execution and accountability for outcomes

• Proven ability to manage CROs and external vendors effectively

• Solid understanding of clinical trial conduct and the drug development process

• Strong cross-functional collaboration and stakeholder partnership skills

• Clear, confident verbal and written communication

• Proactive approach toidentifyingand managing operational risks

• Strong organizational and prioritization skills

• Continuous improvement mindset with a focus onoptimizingprocesses and efficiency

This role involves minimal travel, typically under 10%.