Executive Director, Bioanalytical Development

Role Summary

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 allows 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.

Responsibilities

• 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.

Qualifications

• Ph.D. or equivalent in Biochemistry, Pharmacology, or related field with 10-12+ years of experience in bioanalytical sciences within the biopharmaceutical industry.
• Proven leadership experience managing large, multidisciplinary teams and external partnerships.
• Deep expertise in bioanalytical assay development for biologics and small molecules, including PK, ADA, and biomarker assays.
• Strong understanding of regulatory requirements and experience supporting global regulatory submissions.
• Demonstrated ability to influence cross-functional teams and drive strategic initiatives.
• Excellent communication, organizational, problem-solving and project management skills.
• Experience with overseeing vendors.
• Experience in a fast-paced biotech environment.
• Track record of innovation and scientific contributions in bioanalysis.

Education

• Ph.D. or equivalent in Biochemistry, Pharmacology, or related field.