JOB OVERVIEW

We are seeking a dynamic and experienced Principal Scientist, Biomarker Lead to join our Translational Medicine team. This individual will play a critical role in designing and executing biomarker strategies to support the clinical development of our oligonucleotide-based therapeutics. The ideal candidate will bring deep scientific expertise across proteomics, metabolomics, and molecular biology, along with demonstrated hands-on experience in clinical trial settings and assay development. This is a high-impact, cross-functional role with significant visibility and strategic input across RandD and Clinical.RESPONSIBILITIES

Lead the development and execution of biomarker strategies for clinical programs, with a focus on mechanism-of-action, pharmacokinetic and pharmacodynamic biomarkers, and patient stratification markers.Design and oversee the development, qualification/validation, and implementation of fit-for-purpose biomarker assays (e.g., ELISA, LC-MS/MS, immunoassays, NGS, etc.) in alignment with regulatory and clinical timelines.Apply 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 and integration.Serve as the scientific lead for biomarker-related activities in clinical trials, including protocol development, sample collection plans, and data interpretation.Collaborate with Discovery, Preclinical, and Regulatory to ensure continuity of biomarker strategy throughout all phases of development.Maintain awareness of emerging technologies and regulatory guidance in the biomarker space.Represent the company in external collaborations, scientific meetings, and regulatory interactions as needed.QUALIFICATIONS

PhD in Molecular Biology, Biochemistry, Pharmacology, or related field with 8+ years of industry experience in translational medicine, biomarker development, or related function.Proven track record of biomarker leadership in clinical-stage therapeutic programs, ideally in the context of oligonucleotide therapeutics.Deep hands-on experience in proteomics and metabolomics, including data interpretation and technology selection.Strong assay development and validation experience, including managing external vendors and CROs.Demonstrated experience with central lab management and clinical sample management.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.LOCATION

AIRNA has a hybrid work model, and the role will be based in AIRNA’s corporate headquarters in Cambridge, MA -3 days per week.

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