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 bio marker 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 bio marker 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
You excel in fast-paced clinical development environments dedicated to advancing new therapies to patients. Your expertise in 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-I V 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
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 to identifying and managing operational risks
Strong organizational and prioritization skills
Continuous improvement mindset with a focus on optimizing processes and efficiency
This role involves minimal travel, typically under 10%.
Job Level: Management
Additional Information
The base compensation range for this role is: $122,000.00-$163,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to:
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 compan
Benefits
Dental insuranceVision insurancePaid time offEquity / stock optionsPerformance bonus
Additional Information
About T his R ole:
The Biomarker and Bioanalytical Operations Study Manager leads PK, 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 to the Head of Biomarker and Bioanalytical Operations.
Biogen · San Francisco, CA