[Hiring] Senior Manager, Clinical Biomarker Operations @Apogee Therapeutics

Role Description

Plan track and manage biomarker sample logistics across all our clinical trials, oversee sample shipment and testing at vendors, complete sample reconciliation as needed, plan and inform teams on data delivery timelines and manage final sample disposition.

• Ensure adherence to the clinical study protocol.
• Contribute to biospecimen collection guidelines in protocols, ICF and lab manuals.
• Oversee finalization of data transfer specifications.
• Support the setup and ongoing management of a sample inventory database.
• Participate in the development of a biomarker sample inventory strategy.
• Select third-party vendors for long-term sample storage.
• Oversee the tracking of sample collection.
• Coordinate shipment of samples to external testing partners.
• Support Biomarker related QA activities, including participating in gap analysis of biomarker departmental processes as part of inspection readiness.
• Coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships.
• Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Finance, Procurement and Quality Assurance.
• Support activities related to biomarker budget planning and tracking of accruals.
• Lead vendor selection, performance management and oversight to ensure compliance to Apogee standards.
• Continuously identify and build best practices for process improvements.

Qualifications

• MS or higher with > 3 years or BS with >5 years of direct experience in biomarker operations role.
• Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection through to long-term storage.
• Significant experience with CRO oversight, including contract management, SOW reviews, activity and accrual tracking and final reconciliation of activities.
• Experienced in all phases of clinical trials.
• Good understanding of biomarker assays, including flow cytometry, genomics, protein-based assays and drug development in general.
• High level of emotional intelligence and able to collaborate effectively as a member of cross-functional teams.
• Excellent communication skills to drive projects and manage timelines.
• Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines.
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
• Ability and willingness to travel including a minimum of ~4 times per year for All Hands meetings and other workshops.

Requirements

• The anticipated salary range for candidates for this role will be $150,000-$170,000/year.
• The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless.
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave.
• Commitment to growing you professionally and providing access to resources to further your development.
• Regular all team, in-person meetings to build relationships and problem solve.