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Apogee Therapeutics

Senior Manager, Clinical Biomarker Operations

Posted Yesterday
Be an Early Applicant
Remote
Hiring Remotely in USA
150K-170K Annually
Senior level
Remote
Hiring Remotely in USA
150K-170K Annually
Senior level
Manage biomarker sample logistics, oversee vendor contracts, ensure compliance with clinical protocols, and support biomarker QA activities while collaborating with various stakeholders.
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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 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!

Role Summary
  • Plan track and manage biomarker sample logistics across all our clinical trials, oversee sample shipment and testing at vendors, complete 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, ICF and lab manuals, and oversee finalization of data transfer specifications.
  • Support the setup and ongoing management of a sample inventory database. This includes participating in the development of a biomarker sample inventory strategy, selecting third-party vendors for long-term sample storage, overseeing the tracking of sample collection, and coordinating shipment of samples to external testing partners
  • Support Biomarker related QA activities, including participating in gap analysis of biomarker departmental processes as part of inspection readiness
  • Coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships.
  • Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Finance, Procurement and Quality Assurance.
  • Support activities related to biomarker budget planning and tracking of accruals.
  • Lead vendor selection, performance management and oversight to ensure compliance to Apogee standards
  • Continuously identify and build best practices for process improvements.

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 through 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
  • 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.
  • 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 ~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.


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
  • 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
 
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
 
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
 
To review our privacy policy, click here
 
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Apogee Therapeutics Waltham, Massachusetts, USA Office

221 Crescent St , Waltham, MA , United States, 02453

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