Associate Director Biomarker Lead Job Fall River area,Massachusetts USA,Research/Development

Our client is a clinical-stage biotech company advancing RNA-targeting therapies. They have asked us to assist them in their search for an Associate Director Biomarker Lead.

Major tasks and responsibilities include:

Drive the development and execution of biomarker strategies for clinical programs, with a focus on mechanism-of-action, pharmacodynamic, and patient stratification markers.
Design and lead the development, validation, and implementation of fit-for-purpose biomarker assays, such as ELISA, LC-MS/MS, immunoassays, NGS, etc., ensuring alignment with regulatory and clinical objectives.
Utilize multi-omics approaches (proteomics, metabolomics, transcriptomics) to uncover disease biology and drug response signals that inform clinical decision-making.
Partner closely with Clinical Development, Bioinformatics, Regulatory, and external CROs to ensure high-quality data generation and integration.
Serve as the scientific lead for biomarker components of clinical trials, including protocol development, sample collection plans, and data interpretation.
Partner across functions, including Discovery, Preclinical, and Regulatory, to ensure biomarker strategies are consistently applied throughout all phases of development.
Stay current on advancements in biomarker technologies and regulatory guidance.
Represent the company in external collaborations, scientific meetings, and regulatory interactions as needed.

We seek candidates with the following qualifications:

Must have a PhD in Molecular Biology, Biochemistry, Pharmacology, or related field.
A minimum of 8+ years of industry experience in translational medicine, biomarker development, or related function.
Demonstrated leadership in biomarker strategy within clinical-stage programs.
Experience in nucleic acid-based therapeutics highly preferred.
Hands‑on expertise in omics-based approaches, particularly proteomics and metabolomics, including data interpretation and technology selection.
Strong assay development and validation experience, including managing external vendors and CROs.
Demonstrated experience translating preclinical insights into clinical biomarker strategies and endpoints.
Strategic thinker with excellent problem‑solving skills and the ability to operate effectively in a fast‑paced, matrixed environment.
Outstanding communication and collaboration skills with a demonstrated ability to lead cross‑functional initiatives.

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