Director, Imaging Biomarkers
Dyne Therapeutics
4 months ago
Remote friendly (Waltham, MA)
United States
$196,000 - $240,000 USD yearly
Clinical Research and Development
Primary Responsibilities
- Collaborate with cross-functional teams including clinical development, biostatistics, and regulatory affairs to integrate imaging biomarkers into clinical trial protocols
- Deliver high-quality data supporting internal decision-making and external communications, including regulatory authorities
- Define and execute the imaging biomarker strategy aligned with clinical and translational objectives
- Serve as subject matter expert for imaging biomarkers across pre-clinical and clinical programs
- Lead 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 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
- Oversee vendor selection and budget management for imaging-related activities
- Manage imaging biomarker operations in clinical studies (protocol development, site training, data quality assurance)
- Foster a culture of innovation and scientific rigor
Education/Qualifications
- Ph.D., M.D., or equivalent in Biomedical Engineering, Medical Physics, Radiology, or related scientific disciplines
- 10+ years of experience in imaging biomarker development (pharma, biotech, or academic research)
- Deep scientific expertise in at least one major imaging modality (preferably MRI), including image acquisition, processing, and analysis
- Proven track record 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; able to influence across functions
- Excellent communication and presentation skills
Preferred Experience/Skills
- Familiarity with AI/ML for image analysis
- Understanding/implementation of digital biomarkers using wearables, sensors, or digital health technologies
- Knowledge of disease-specific imaging biomarkers (e.g., neurology, cardiology, neuromuscular)
MA Pay Range
- $196,000 - $240,000 USD
- Collaborate with cross-functional teams including clinical development, biostatistics, and regulatory affairs to integrate imaging biomarkers into clinical trial protocols
- Deliver high-quality data supporting internal decision-making and external communications, including regulatory authorities
- Define and execute the imaging biomarker strategy aligned with clinical and translational objectives
- Serve as subject matter expert for imaging biomarkers across pre-clinical and clinical programs
- Lead 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 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
- Oversee vendor selection and budget management for imaging-related activities
- Manage imaging biomarker operations in clinical studies (protocol development, site training, data quality assurance)
- Foster a culture of innovation and scientific rigor
Education/Qualifications
- Ph.D., M.D., or equivalent in Biomedical Engineering, Medical Physics, Radiology, or related scientific disciplines
- 10+ years of experience in imaging biomarker development (pharma, biotech, or academic research)
- Deep scientific expertise in at least one major imaging modality (preferably MRI), including image acquisition, processing, and analysis
- Proven track record 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; able to influence across functions
- Excellent communication and presentation skills
Preferred Experience/Skills
- Familiarity with AI/ML for image analysis
- Understanding/implementation of digital biomarkers using wearables, sensors, or digital health technologies
- Knowledge of disease-specific imaging biomarkers (e.g., neurology, cardiology, neuromuscular)
MA Pay Range
- $196,000 - $240,000 USD