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Apogee Therapeutics · 2 days ago

Senior Manager, Clinical Biomarker Operations

Boston, MA

Full-time

Hybrid

Senior Level

$160K/yr - $175K/yr

5+ years exp

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of various inflammatory and immunology indications. The Senior Manager, Clinical Biomarker Operations will manage logistics around biomarker sample collection and ensure compliance with clinical study protocols while collaborating with various stakeholders.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake 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, ICFs, and lab manuals, and lead finalization of data transfer specifications

Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions

Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance

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

Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards

Continuously identify and build best practices for process improvements

Ensure high quality data generation by overseeing sample integrity and external collaborations

Qualification

Biomarker sample managementCRO oversightClinical trial experienceBiomarker assaysBudget managementProcess improvementEmotional intelligenceCross-functional collaborationCommunication skills

Required

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 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, Phase 3 experience is an asset

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

Experience in I&I indications

Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines

Successfully exhibits 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

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

We provide 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

Apogee offers regular all team, in-person meetings to build relationships and problem solve

Company

Apogee Therapeutics

Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.

Founded in 2022

San Francisco, California, USA

201-500 employees

https://apogeetherapeutics.com/

H1B Sponsorship

Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (3)