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 is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.
We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.
If this sounds like you, keep reading!The Department of Research and Translational Medicine is seeking a Clinical Biomarker Operations Sr. Manager. This person will have direct experience in clinical biomarker sample management and analysis, CRO interactions, contracts, and budget management.
Key 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.
Ideal Candidate
- 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.
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.
- 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
- 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
Skills Required
- MS or higher with > 3 years or BS with >5 years of direct experience
- Experience with biomarker sample management and logistics
- Significant experience with CRO oversight including contract management
- Experience in all phases of clinical trials, particularly Phase 3
- Good understanding of biomarker assays and drug development
- Ability and willingness to travel at least ~4 times per year
What We Do
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
