Dyne Therapeutics · 1 day ago
Executive Director, Bioanalytical Development
Waltham, MA
Full-time
Onsite
Director/Executive
$242K/yr - $296K/yr
12+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Executive Director, Head of Bioanalytical Development leads the bioanalytical capabilities to develop, validate, and implement robust assays for clinical programs, ensuring compliance with regulatory standards and collaborating across multiple teams.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
Company
Dyne Therapeutics
Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
51-200 employees
H1B Sponsorship
Dyne Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (7)
2023 (1)
2022 (3)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Hercules CapitalAtlas Venture
2025-12-09Post Ipo Equity· $402.5M
2025-06-30Post Ipo Equity· $230M
2025-06-30Post Ipo Debt· $100M
Leadership Team
John Cox
Chief Executive Officer
Recent News
2026-01-11
2026-01-07
2025-12-24
Company data provided by crunchbase