Executive Director, Bioanalytical Development

Executive Director, Bioanalytical Development

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

The Executive Director, Head of Bioanalytical Development will lead the bioanalytical capabilities and work on our programs to develop, validate and implement robust PK and immunogenicity assays that allow accelerated transition from the bench to the clinic, from discovery through IND, late-stage clinical development and licensure. This role will help lead and build internal capability for ligand binding, mass spectrometry and molecular assay development of PK and ADA for Dyne Therapeutics' portfolio. In addition, this role will lead the selection of strategic partner labs for the use of these assays in toxicology studies and clinical trials in keeping with all applicable regulatory expectations. This position will report to the head of Translational Biomarkers at Dyne Therapeutics. The role will work collaboratively across multiple research and clinical teams for the development, technology transfer and oversight of vendors running those bioanalytical assays to support preclinical studies and clinical trials conducted by Dyne Therapeutics.

This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.

Primary Responsibilities Include :

• Lead and evolve the Bioanalytical Development function, overseeing assay development, validation, and implementation for PK and immunogenicity endpoints.
• Develop and execute strategic plans aligned with pipeline priorities, ensuring timely and high-quality data delivery.
• Build and mentor a high-performing team with diverse technical expertise and an innovative mindset.
• Serve as the primary scientific interface with CROs and external partners, ensuring alignment on quality, timelines, and regulatory compliance.
• Collaborate cross-functionally with Clinical Pharmacology, Preclinical Development, Regulatory Affairs, Quality Assurance, and Therapeutic Area leads to support integrated development strategies.
• Ensure compliance with global regulatory standards (FDA, EMA, ICH, GCP, GLP) and contribute to regulatory filings (IND, BLA, MAA).
• Champion the adoption of cutting-edge technologies and methodologies in bioanalysis, including ligand-binding assays, LC-MS / MS, and cell-based assays.
• Drive continuous improvement initiatives and implement best practices in bioanalytical operations and data integrity.

Education and Skills Requirements :

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.