Director, Imaging Biomarkers
Functional Improvement · Waltham, MA · 2 days ago
Healthcare$196k–$240k/yrFull-time
Primary Responsibilities
- 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)
Pay Range
$196,000—$240,000 USD