Director, Imaging Biomarkers
Dyne TherapeuticsAbout the role
Company Overview:
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 Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a 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 at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Director of Imaging Biomarkers leads the development and execution of innovative imaging strategies across Dyne’s therapeutic programs. This pivotal role will ensure that imaging biomarker strategies are scientifically rigorous, clinically relevant, and conducive to robust therapeutic development. The person in this role focuses on enhancing the understanding of disease mechanisms, patient populations, evaluating therapeutic efficacy, and supporting clinical trial designs through innovative imaging approaches. This role is critical to linking early phase research to clinical development, providing essential insights that drive decision making. The person in this role leverages their expertise in various imaging modalities to develop novel biomarker applications that assess therapeutic efficacy, drive patient-centric trial designs, and facilitate regulatory approval processes. This role combines scientific depth with strategic vision, driving the discovery, validation, and application of advanced imaging modalities to enable precision medicine and accelerate drug development. The person in this role serves as a trusted expert and collaborative leader, fostering innovation and ensuring scientific rigor in both preclinical and clinical settings.
This role is based in Waltham, MA.
Primary Responsibilities Include:
- Collaborate with cross-functional teams including clinical development, biostatistics, and regulatory affairs to ensure that imaging biomarkers are effectively integrated into clinical trial protocols
- Enable the delivery of high-quality data supporting both internal decision making and external communications with stakeholders, including regulatory authorities
- Define and execute the imaging biomarker strategy aligned with clinical and translational objectives
- Serve as the subject matter expert for imaging biomarkers across pre-clinical and clinical programs
- Lead the development, validation, and qualification of imaging biomarkers for disease characterization, patient stratification, and pharmacodynamic assessment
- Partner with Clinical Development, Translational Biomarkers, Biostatistics, Data Management and Regulatory teams to integrate imaging biomarkers into Dyne clinical trials
- Evaluate and implement cutting-edge imaging technologies (e.g., MRI, PET, CT, ultrasound, optical imaging)
- Ensure compliance with regulatory standards for imaging biomarker development and qualification
- Collaborate with external imaging CROs, academic institutions, and technology vendors to deploy imaging biomarkers into Dyne clinical trials
- Oversee vendor selection and budget management for imaging-related activities
- Manage imaging biomarker operations in clinical studies including protocol development, support site training, and data quality as
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