Senior Manager, Clinical Biomarker Operations

Apogee Therapeutics; United States; Remote; USD 130,000 - 155,000; Full time

Job summary

An innovative biotechnology company seeks a Senior Manager for Clinical Biomarker Operations. This dynamic role involves overseeing biomarker sample management, ensuring high-quality data generation, and collaborating with cross-functional teams. The ideal candidate will have extensive experience in biomarker operations, a strong understanding of CRO interactions, and excellent communication skills. Join a fast-paced environment committed to reshaping the standard of care in inflammatory and immune diseases, where you can contribute to a vibrant company culture and enjoy competitive compensation and benefits.

Benefits

Flexible PTO

Performance Bonus

Equity Grant Opportunities

Health Benefits

Retirement Benefits

Company-wide Shutdowns

Professional Development Resources

In-person Team Meetings

Qualifications

• PhD with >3 years, MS with >6 years, or BS with >8 years in biomarker operations.
• Good understanding of biomarker assays and CRO interactions.

Responsibilities

• Manage logistics around biomarker sample collection and testing in clinical trials.
• Ensure high-quality data generation and oversee external collaborations.
• Support vendor management and contract finalization for clinical activities.

Skills

Biomarker Operations

CRO Interactions

Contracts Management

Drug Development

Flow Cytometry

Genomics

Protein Assays (LBA, LCMS)

Cross-Functional Collaboration

Communication Skills

Education

PhD in relevant field

MS in relevant field

BS in relevant field

Job description

Senior Manager, Clinical Biomarker Operations

Remote

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient, and Egoless.

If this sounds like you, keep reading!

Role Summary

The Department of Research and Translational Medicine is seeking a Sr. Manager, Clinical Biomarker Operations. This person will have direct experience in clinical biomarker sample management and analysis, CRO interactions, and contracts and budget management.

Key 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, and manage 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.

Ideal Candidate

• PhD with >3 years of pharmaceutical/biotech industry experience, MS with >6 years, or BS with >8 years of direct experience in a 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, with excellent communication skills to drive projects, manage timelines, and present to a variety of stakeholders while tailoring messages accordingly.
• Enjoys a fast-paced environment, is flexible, and able to manage multiple and competing priorities under tight timelines.
• Successfully exhibits Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless.
• Position requires approximately 10% travel to All Hands meetings and other workshops.

The anticipated salary range for candidates for this role will be $130,000-$155,000/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.

What We Offer

• 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.