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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 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

  • 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.

Ideal Candidate 

  • 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.

The anticipated salary range for candidates for this role will be $130,000-$150,000. 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
 
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

 

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