Director, Imaging Biomarkers

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 assurance 
• Foster a culture of innovation and scientific rigor 

Education and Skills Requirements: 

• Ph.D., M.D., or equivalent in Biomedical Engineering, Medical Physics, Radiology, or related scientific disciplines 
• 10+ years of experience in imaging biomarker development within pharma, biotech, or academic research 
• Blend of technical knowledge, scientific acumen, and strategic vision to foster collaborations with academic institutions, industry partners, and clinical experts  
• Deep scientific expertise in at least one major imaging modality (preferably MRI) and a strong understanding of image acquisition, processing, and analysis 
• Proven track record in applying imaging biomarkers in clinical trials and regulatory submissions 
• Expertise in quantitative imaging methodologies, image analysis software, and imaging data interpretation 
• Strong leadership and project management skills with ability to influence across functions 
• Excellent communication and presentation skills 

Preferred Experience: 

• Familiarity with AI/ML approaches for image analysis to improve efficiency, accuracy, and uncover complex patterns in imaging data 
• Understanding and implementation of digital biomarkers using wearables, sensors, or other digital health technologies 
• Knowledge of disease-specific imaging biomarkers (e.g., neurology, cardiology or neuromuscular)