Jobs · Healthcare · Massachusetts

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

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