Senior Manager Clinical Biomarker Operations
Senior Manager Clinical Biomarker Operations
Posted on :
31-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
31-01-2025
Job Description
Job Title: Senior Manager Clinical Biomarker Operations
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
About Apogee Therapeutics
Founded in 2022 Apogee Therapeutics Inc. (Ticker: APGE) is a wellfunded Nasdaq listed company that offers the opportunity to work in a fastpaced 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 wellestablished mechanisms of action and incorporating advanced antibody engineering to optimize halflife 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 fastpaced 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
What We Offer
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
Founded in 2022 Apogee Therapeutics Inc. (Ticker: APGE) is a wellfunded Nasdaq listed company that offers the opportunity to work in a fastpaced 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 wellestablished mechanisms of action and incorporating advanced antibody engineering to optimize halflife 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 fastpaced 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 shortterm and longterm 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.
- 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 crossfunctional 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.
- Position requires approximately 10% travel to All Hands meetings and other workshops.
What We Offer
- A great culture grounded in our C.O.R.E. values: Caring Original Resilient and Egoless
- Opportunity to work in a fastpaced 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 oneweek companywide shutdowns each year
- Commitment to growing you professionally and providing access to resources to further your development
- Apogee offers regular all team inperson meetings to build relationships and problem solve
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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Employment Type
Full Time
Key Skills
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