Apogee Therapeutics
Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.
Immunology & Inflammation
51 - 200
Senior Manager, Clinical Biomarker Operations
2 days ago
🏡 Remote – Anywhere in California
Apogee Therapeutics
Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.
Immunology & Inflammation
51 - 200
Description
• 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.
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 • Ability and willingness to travel including a minimum of ~3 times per year for All Hands meetings and other workshops.
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 • 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
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