Principal Scientist/Associate Director, Clinical Biomarkers

AIRNA; Cambridge (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

A biotechnology company in Cambridge, MA is seeking a Principal Scientist/Associate Director, Clinical Biomarkers to lead the development and execution of biomarker strategies for clinical programs. This role focuses on designing biomarker assays and collaborating closely with cross-functional teams to inform clinical decision-making. Candidates should have a PhD in Molecular Biology or a related field, alongside significant experience in translational medicine and clinical trial settings. The role supports a hybrid work model, providing flexibility in work arrangements.

Qualifications

• 8+ years of industry experience in translational medicine or biomarker development.
• Proven track record in clinical-stage therapeutic programs.
• Strong experience in assay development and validation.
• Hands-on experience with proteomics/metabolomics and data interpretation.

Responsibilities

• Lead biomarker strategies for clinical programs.
• Design and oversee development of biomarker assays.
• Collaborate with Clinical Development and Regulatory teams.
• Serve as scientific lead for biomarker activities in clinical trials and data interpretation.

Skills

Biomarker leadership

Proteomics

Metabolomics

Assay development

Clinical trial experience

Data analysis

Cross-functional collaboration

Education

PhD in Molecular Biology or related field

Tools

ELISA

LC-MS/MS

Immunoassays

NGS

Job description

AIRNA is a biotechnology company with a mission to be the leading RNA editing company delivering precision therapies to patients with rare and common diseases.

AIRNA is harnessing advances in genetics to develop transformative RNA-editing medicines that improve human health. Our proprietary platform is based on groundbreaking research by pioneers of the field and company co-founders Thorsten Stafforst (University of Tübingen) and Jin Billy Li (Stanford University) and enables optimal potency, safety, and delivery. AIRNA is advancing a robust pipeline of therapeutic candidates that are designed to provide functional cures for severe or chronic diseases by repairing harmful genetic variants or introducing beneficial variants promote optimal health.

AIRNA has raised $245 million in financing from a world-class syndicate of investors including Arch Venture Partners, Forbion, Venrock Healthcare Capital Partners, RTW Investments, Nextech Invest, and ND Capital. We value teamwork, resilience, excellence, human, and health, and have a diverse team at both our headquarters in Cambridge, MA and our research operations in Tübingen, Germany.

JOB OVERVIEW

We are seeking a dynamic and experienced Principal Scientist/Associate Director, Clinical Biomarkers 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 generation 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.