Senior Manager, Biomarker Operations to help advance innovative clinical programs by shaping and executing biomarker sample strategies across studies. This is an exciting opportunity for a collaborative, detail-oriented operations professional who enjoys partnering across scientific, clinical, and vendor teams, solving complex challenges, and improving processes that support high-quality study execution. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities- Lead day-to-day biomarker sample operations for clinical studies, including sample logistics, issue resolution, protocol amendments, lab manual updates, study initiation materials, and escalation of study-related risks.
- Partner with Translational and Clinical teams to design and implement innovative, feasible biospecimen collection and handling approaches that uphold quality, ethical, and informed consent standards.
- Maintain accurate sample inventories and oversee short- and long-term sample storage solutions.
- Collaborate with cross-functional stakeholders, including Translational Scientists, Medical Monitors, Clinical Operations, Finance, Procurement, Legal, Data Management, and Quality Assurance.
- Work with Quality Assurance to support vendor qualification and audit activities.
- Manage CROs and external laboratories to ensure key deliverables, timelines, sample processing, testing, and data reporting meet study specifications and business requirements.
- Organize and facilitate meetings with internal and external stakeholders to support alignment and timely execution.
- Oversee central lab budgets, contracts, MSAs, legal agreements, and other agreements related to clinical biomarker activities, laboratories, and partnerships.
- Coordinate with Clinical and IT teams to manage data reporting from CROs into Fate and clinical study vendor systems, as appropriate.
- Provide cross-functional study updates to clinical study and biomarker teams, including sample collection, assay status, and analysis updates.
- Develop and update SOPs for cross-functional biomarker operational processes.
Qualifications- MS or higher degree with 3+ years of experience in biomarker operations, or BS degree with 5+ years of relevant experience.
- Demonstrated experience managing clinical or biomarker operations from study initiation through completion, including collaboration with central labs and CROs to execute biomarker study plans.
- Experience working with clinical trial sites and related clinical CROs.
- Knowledge of cancer biology, immunology, biomarkers, drug development, and clinical trial methodology is a plus.
- Experience with one or more Laboratory Information Management Systems (LIMS) is strongly preferred.
- Prior experience or familiarity with IND preparation and filing is preferred.
- Strong planning, organization, and follow-through, with the ability to manage multiple high-priority projects and competing deadlines in a dynamic environment.
- Excellent interpersonal, verbal, written communication, presentation, and influencing skills.
- High emotional intelligence and a collaborative approach to working effectively across cross-functional teams.
- Innovative mindset with the ability to introduce new ideas, improve processes, and solve problems creatively.
- Flexibility in schedule and willingness to travel as needed.
Working Conditions & Physical Requirements- Travel may be required (up to 10%).
- Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Compensation- The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
- Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
- The anticipated salary range for this role is $150,000 - $165,000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
