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. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Executive Director, Head of Bioanalytical Development leads the bioanalytical capabilities and works 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 helps 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 leads 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 reports to the Head of Translational Biomarkers at Dyne Therapeutics. The role works 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. 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:
- Ph.D. or equivalent in Biochemistry, Pharmacology, or related field with 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.
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The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
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.
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Dyne Therapeutics Waltham, Massachusetts, USA Office
1560 Trapelo Rd, Waltham, MA, United States, 02451
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