Manager, Clinical Biomarker Assays, Translational Science - Neuroscience

Position Summary

We are seeking a highly motivated Manager, Clinical Biomarker Assays, Translational Science, Neuroscience with biomarker expertise to lead and execute clinical biomarker assay development, validation and implementation activities to support our neuroscience clinical programs. This individual will perform as the Clinical Biomarker Assay Lead within Translational Science to support Neuroscience programs, and will be responsible for clinical biomarker CROs evaluation and oversight, clinical biomarker assay development and validation, clinical sample testing execution, and high‑quality biomarker data generation and transfer to support assessment of pharmacodynamics including target engagement, patient stratification, and disease progression.

The successful candidate will combine strong scientific rigor with cross‑functional leadership and a track record of overseeing development of biomarker assays for utilization in clinical studies.

This position reports to Director, Translational Science – Neuroscience and can be located in our headquarters in New Haven, CT or work remotely from a location within the U.S.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

• Conduct scientific and operational due diligence and selection of external biomarker CROs and assay platforms, leading vendor due diligence processes including, but not limited to assessment of biomarker technology, evaluations of biomarker assay feasibility, analytical performance and validation characteristics, and overall technical capability.
• Lead and oversee development, qualification, and validation of clinical biomarker assays (e.g., ELISA, Simoa, MSD, LC‑MS/MS, Olink/SomaScan, NGS) in collaboration with internal teams and CROs, including review of assay analytical validation plans, biomarker reports, and technical documentation to ensure timely clinical biomarker assay deliverables and biomarker assay performance meets regulatory and industry standards for clinical use (e.g., GCLP, CLIA, CAP as applicable).
• Oversee external CROs/labs performing clinical biomarker testing, including vendor management, assay transfer and clinical sample testing. Ensure high‑quality biomarker data generation, QC, and timely data transfer.
• Cross‑functional collaboration with Translational Science Lead, Clinical Operations, Biosample Operations, Data Management, and external vendors to ensure execution of biomarker readouts in our clinical studies.

Qualifications

Required Qualifications

• 5+ years (industry preferred) in clinical biomarker assay development and/or bioanalytical sciences.
• Demonstrated experience managing external CROs and central laboratories.
• Demonstrated experience with protein biomarkers (e.g., fluid including CSF, tissue, blood‑based) and genomic platforms (e.g., Simoa, MSD, Olink, mass spectrometry, NGS).
• Experience with neuroimaging biomarkers (e.g., PET, MRI) and/or digital biomarkers preferred.
• Familiarity with clinical data standards and biomarker data transfer processes.
• Experience in neuroscience and/or rare diseases such as Parkinson’s disease, PSP, Alzheimer’s disease, or related disorders preferred.
• Experience supporting IND‑enabling or early‑phase clinical trials preferred.
• Demonstrated success in working cross‑functionally within multidisciplinary teams.
• Excellent communication, organizational, and problem‑solving skills, with the ability to operate independently in a matrixed environment.
• Arvinas will not provide VISA sponsorship for this position; applicants must be able to work without current or future VISA sponsorship.
• The duties of this role are generally conducted in a combination of company office and home office environments. Employees must be able to use a computer, engage in communications via phone, video, and electronic messaging, problem‑solve, analyze and dialogue, collaborate with others, and maintain general availability during standard business hours.

Education

• D. in Neuroscience, Neurobiology, Molecular Biology, Pharmacology, or a related life science field.

Benefits

Arvinas offers a competitive package of base and incentive compensation plus a comprehensive benefits program designed to support the health, wellness, and financial security of employees and their families. Benefits include group medical, vision, and dental coverage, group and supplemental life insurance, and more. For more information, visit

Arvinas is an equal‑opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.