Senior Manager, Clinical Biomarker Operations

Summary

Join Apogee Therapeutics, a fast-growing biotechnology company, as a Sr. Manager, Clinical Biomarker Operations. You will play a key role in managing biomarker sample collection, analysis, and logistics across clinical trials. Responsibilities include overseeing sample management, vendor interactions, data delivery, and budget tracking. The ideal candidate possesses a PhD or equivalent experience in biomarker operations within the pharmaceutical/biotech industry. Apogee offers a competitive compensation and benefits package, including a performance bonus, equity grants, flexible PTO, and professional development opportunities. This position requires approximately 10% travel.

Requirements

• PhD with >3 years of pharmaceutical/biotech industry experience, MS with > 6 years or BS with >8 years of direct experience in biomarker operations role
• Good understanding of biomarker assays, CRO interactions, contracts management, and drug development in general
• Prior experience in biomarker sample analysis with CROs and internal labs using flow cytometry, genomics and protein (LBA, LCMS) based assay approaches
• Experience in I&I indications
• Highly experienced in leading and collaborating effectively as a member of cross-functional teams, excellent communication skills to drive projects and manage timelines and present to a variety of stakeholders and tailor message accordingly
• 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

Responsibilities

• Track and manage logistics around biomarker sample collection across all our clinical trials
• Oversee sample shipment to vendors
• Undertake sample reconciliation as needed
• Oversee sample testing
• Plan and inform teams on data delivery timelines and manage final sample deposition
• Develop robust processes to facilitate the planning, coordination, and testing of clinical samples
• Ensure high quality data generation by overseeing external collaborations
• Maintain sample inventories, coordinate sample collection, short-term and long-term sample storage solutions
• Work in close collaboration with relevant stakeholders including Data Management, Clinical Operations, Finance, Procurement and Quality Assurance
• Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICF and lab manuals, and oversee finalization of data transfer specifications
• Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships
• Support QA in vendor audit and inspection activities
• Support activities related to biomarker budget planning and tracking of accruals
• Vendor identification, management and oversight
• Continuously identify and build best practices for process improvements

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• 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
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve