Biomarker Operations Manager

Roche • South San Francisco, CA

9d • $188

About The Position

The Biomarker Operations Manager (BOM) develops and executes operational plans to deliver on biomarker strategies across clinical trials, translational research/disease areas and technology. The BOM ensures the successful planning and end-to-end delivery of biomarker strategies by collaborating with Translational Medicine Scientists, Disease Area Leads (DALs), technology leaders, clinical study teams, internal labs, and external vendors. In this role, the BOM acts as a single point of contact for operational execution of TM-led strategies. This portfolio-aligned role offers the flexibility to work across clinical program work, disease area projects, and technology-driven initiatives. Individuals in this position will have the opportunity to contribute to all three domains and enable high-impact operational strategies that align with scientific and clinical program priorities. The BOM role may work across the three different areas or be entirely dedicated to one or more areas.

Requirements

• Understanding of clinical development processes, biomarker operations, translational research and drug development
• Ability to execute role under supervision and contribute ideas and expertise within the immediate project team and Biomarker Operations function
• Effective collaboration with BOM team members, actively seeking advice, sharing knowledge, and fostering a positive working environment
• Strong project management and organizational skills
• Excellent communication, influencing, and stakeholder management skills
• Strategic mindset with a focus on problem-solving, negotiation, and delivering results in complex and dynamic environments
• Education: Bachelor’s degree in Biosciences or a related technical field.
• Biomarker Operations Manager Level (Up to 3 years): Entry-to-mid level experience in clinical or translational research settings.
• Senior Biomarker Operations Manager Level (3–6 years): Proven track record in clinical/translational research, specifically including 1–3 years dedicated to biomarker operation

Nice To Haves

• Familiarity with relevant ethics and regulatory requirements, including ICH/GCP and IVDR standards preferred

Responsibilities

• Create operational plans for biomarker strategies and oversee all activities required to manage the lifecycle of biomarker samples across clinical and translational research programs, including collection, processing, shipment, storage, analysis, and final disposition
• Partner with internal and external stakeholders to enable key components of the biomarker strategy, enabling assay development/validation, outsourcing, sample procurement, academic/industry collaborations, and technology evaluations
• Vendor management, including establishing and managing relationships with central labs, diagnostic partners and biomarker testing laboratories, ensuring timely and high-quality data delivery
• Represent biomarker operations on cross-functional teams, including clinical study teams, Translational Medicine Subteams (TMSTs), Disease Area Teams (DATs), and Technology Teams
• Support regulatory compliance for biomarker operations, including IVDR requirements, health authority questions, and ethics committee interactions

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level