🚀 Principal Scientist, Biomarker Lead

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 R&D 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.