Manager, Biomarkers and Bioanalytical Operations

Role Overview

• 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 management expertise to Study Management Teams (SMTs) and Biomarker Sub-Teams (BMSTs)
• Ensure compliant, high-quality biomarker and bioanalytical sample collection 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-specific biomarker and bioanalytical sample collection, handling, analysis, transport, and storage strategies
• Partner cross-functionally (Clinical Biomarker, Clinical Pharmacology, Clinical Operations, Data Management, Business Operations & Contracts Partner) to enable efficient execution of the study
• Define data collection, transfer, and reconciliation requirements with data management, bioanalytical leads, and vendors
• Identify operational risks, implement mitigation plans, and support interim and final biomarker and bioanalytical reporting
• 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

Requirements

• 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-IV clinical 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.

Tech Stack

• Google Cloud Platform

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short
• and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation