Treeline
Join to apply for the
Clinical Biomarkers Lead
role at
Treeline
The
Clinical Biomarkers Lead
will be accountable for biomarker planning and execution across all clinical programs. This includes designing biomarker plans for each program, identifying appropriate bioassay labs/CROs, managing assay transfer and validation studies, and ensuring biomarker data are ingested, tracked, QCed, and integrated efficiently. The successful candidate will serve as the central point of accountability for biomarker operations, enabling high‑quality and timely data delivery that supports Treeline's mission to advance precision medicine.
Responsibilities
Develop and oversee biomarker plans for each clinical protocol.
Identify and qualify bioassay labs/CROs for biomarker assays.
Lead assay transfer from Discovery/Translational teams to bioassay labs/CROs, ensuring validation and qualification.
Work with Clinical Operations to implement sample logistics across all studies.
Oversee testing at bioassay labs/CROs, ensuring quality, compliance, and adherence to protocol requirements.
Define and manage data ingestion processes, ensuring biomarker data are QC'ed and integrated into study databases.
Collaborate with Clinical Development, Clinical Operations, Translational Biology, Data Management, Biostatistics, and Regulatory to ensure biomarker deliverables align with clinical program needs.
Provide updates on biomarker sample status, testing timelines, and data readiness to internal stakeholders.
Establish and refine best practices, SOPs, and KPIs for sample management, testing, and biomarker data flow.
Work with Translational Biology and Clinical Development colleagues to analyze biomarker data and test key program hypotheses.
Qualifications
Advanced degree (PhD, MS, or equivalent) in Life Sciences, Cell Biology, Molecular Biology, Immunology, or a related field.
7+ years of experience in clinical biomarkers, translational medicine, or related function within biotech/pharma.
Proven expertise in assay transfer, validation, and qualification with CRO and lab oversight experience.
Knowledge of biomarker assay platforms (flow cytometry, IHC, NGS, proteomics, ligand binding assays) and their clinical application.
Experience in sample tracking, reconciliation, and biomarker data ingestion processes.
Familiarity with ICH‑GCP, regulatory expectations, and data integration standards (e.g., CDISC, SDTM).
Excellent organizational, cross‑functional leadership, and communication skills, with the ability to manage multiple programs in a fast‑paced environment.
Oncology experience strongly preferred. Immunology and/or neuroscience experience considered upside.
Experience with development of companion diagnostics (CDx) considered a plus.
Salary Position is classified as exempt. Annual base salary range for candidates in San Diego: $175,950 to $215,000. Final base salary will depend on experience, education, and other factors. Treeline is a multi‑state employer; salary may differ for other locations.
Recruitment Fraud Statement Please be aware of recruitment fraud and related job scams. Keep the following in mind to protect yourself:
Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
We do not conduct interviews through Skype or Telegram.
Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
To report job scams, head to ReportFraud.ftc.gov.
Notice to Search Firms / Third‑Party Recruitment Agencies: The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties, we will only accept resumes from a recruiter with an executed search agreement. Unsolicited resumes from recruiters are not considered a relationship and do not obligate us to pay fees if we hire from those resumes.
#J-18808-Ljbffr
Clinical Biomarkers Lead
role at
Treeline
The
Clinical Biomarkers Lead
will be accountable for biomarker planning and execution across all clinical programs. This includes designing biomarker plans for each program, identifying appropriate bioassay labs/CROs, managing assay transfer and validation studies, and ensuring biomarker data are ingested, tracked, QCed, and integrated efficiently. The successful candidate will serve as the central point of accountability for biomarker operations, enabling high‑quality and timely data delivery that supports Treeline's mission to advance precision medicine.
Responsibilities
Develop and oversee biomarker plans for each clinical protocol.
Identify and qualify bioassay labs/CROs for biomarker assays.
Lead assay transfer from Discovery/Translational teams to bioassay labs/CROs, ensuring validation and qualification.
Work with Clinical Operations to implement sample logistics across all studies.
Oversee testing at bioassay labs/CROs, ensuring quality, compliance, and adherence to protocol requirements.
Define and manage data ingestion processes, ensuring biomarker data are QC'ed and integrated into study databases.
Collaborate with Clinical Development, Clinical Operations, Translational Biology, Data Management, Biostatistics, and Regulatory to ensure biomarker deliverables align with clinical program needs.
Provide updates on biomarker sample status, testing timelines, and data readiness to internal stakeholders.
Establish and refine best practices, SOPs, and KPIs for sample management, testing, and biomarker data flow.
Work with Translational Biology and Clinical Development colleagues to analyze biomarker data and test key program hypotheses.
Qualifications
Advanced degree (PhD, MS, or equivalent) in Life Sciences, Cell Biology, Molecular Biology, Immunology, or a related field.
7+ years of experience in clinical biomarkers, translational medicine, or related function within biotech/pharma.
Proven expertise in assay transfer, validation, and qualification with CRO and lab oversight experience.
Knowledge of biomarker assay platforms (flow cytometry, IHC, NGS, proteomics, ligand binding assays) and their clinical application.
Experience in sample tracking, reconciliation, and biomarker data ingestion processes.
Familiarity with ICH‑GCP, regulatory expectations, and data integration standards (e.g., CDISC, SDTM).
Excellent organizational, cross‑functional leadership, and communication skills, with the ability to manage multiple programs in a fast‑paced environment.
Oncology experience strongly preferred. Immunology and/or neuroscience experience considered upside.
Experience with development of companion diagnostics (CDx) considered a plus.
Salary Position is classified as exempt. Annual base salary range for candidates in San Diego: $175,950 to $215,000. Final base salary will depend on experience, education, and other factors. Treeline is a multi‑state employer; salary may differ for other locations.
Recruitment Fraud Statement Please be aware of recruitment fraud and related job scams. Keep the following in mind to protect yourself:
Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
We do not conduct interviews through Skype or Telegram.
Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
To report job scams, head to ReportFraud.ftc.gov.
Notice to Search Firms / Third‑Party Recruitment Agencies: The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties, we will only accept resumes from a recruiter with an executed search agreement. Unsolicited resumes from recruiters are not considered a relationship and do not obligate us to pay fees if we hire from those resumes.
#J-18808-Ljbffr