Senior Director – Science

Senior Director, Science, leads the Science team and is the senior scientific voice of Voiant Clinical, with ownership of how independent image review and endpoint adjudication are designed and delivered across the Medical Imaging (IMG) and Endpoint Adjudication (EAC) service lines. This individual partners directly with sponsors to design read paradigms, sets the scientific standard for study documentation, and shapes the Science component of Voiant’s AI and innovation roadmap. The role works closely with Clinical Project Management, Data Management, Image Management, Read Services, Technical Delivery, Quality Assurance, and Business Development, as well as Readers and Adjudication Committee members (external reviewers), and leads a globally distributed team of therapeutic area scientific and medical directors and medical research scientists.

Responsibilities & Accountabilities

• Lead and manage the Science department as owner of the group, including imaging and adjudication Science delivery against study requirements.
• Serve as the scientific subject matter expert to other departments, including, but not limited to Clinical Operations, Data Management, Technical Delivery, and Innovation.
• Own the scientific direction and standards for independent image review and endpoint adjudication across all therapeutic areas (e.g., oncology, neurology, cardiology, respiratory, hematology, immunology, and musculoskeletal) and service lines, including a consistent scientific operating model of processes and best practices.
• Partner with sponsors to design read paradigms, including reader number and roles, blinding, adjudication triggers and rules, timepoint and global reads, eligibility reads, progressive disease (PD) confirmation, and accelerated turnaround requirements.
• Shape and lead the Science component of Voiant’s AI and innovation roadmap, including evaluation and adoption of AI-assisted read tools, quantitative imaging methods, and emerging modalities, and define the scientific validation approach so that innovation remains defensible in regulated studies.
• Lead, mentor, and develop a globally distributed team of therapeutic area scientific and medical directors and medical research scientists, including assignment of scientific resources to projects, resource planning and forecasting, and escalation of resource issues.
• Provide scientific leadership for MRI neuroimaging, including brain tumor, neurodegenerative, and neuroinflammatory indications and quantitative or volumetric MRI endpoints.
• Lead interpretation and implementation of new and evolving response criteria and assessment methods, including RECIST 1.1, iRECIST, RANO / RANO 2.0, and other disease-specific criteria across the portfolio, and maintain current knowledge of FDA, EMA, and other regulatory expectations for imaging endpoints and independent review.
• Serve as the internal and external point of escalation for Science, including scientific guidance and review for therapeutic area scientific and medical directors, and complex imaging, methodological, and read-related questions arising during study conduct.
• Provide scientific input on protocol imaging sections, endpoint definitions, and image acquisition requirements.
• Lead or oversee authorship and scientific review of Independent Review Charters, Adjudication Charters, Imaging Manuals, Reader training materials, and read rules, and review Data Transfer Specifications and query responses for scientific accuracy.
• Ensure read designs are operationally feasible, aligned with contracted scope, and defensible in audits and regulatory inspections.
• Remain hands-on in selected high-impact studies, performing project-specific science tasks where required.
• Provide scientific oversight of endpoint adjudication, including event definitions and adjudication workflows.
• Support with qualification, selection, training, and calibration of Readers and Adjudication Committee members, including recruitment and management of external experts.
• Oversee read monitoring, including inter- and intra-reader variability and adjudication rate trends, and lead corrective actions.
• Serve as the senior scientific advisor to sponsors in governance, kick-off, and investigator meetings.
• Provide scientific consultation to Business Development, including proposals, RFP and RFI responses, bid defenses, and capability presentations, and partner with Clinical Operations and Business Development to scope scientific work accurately in Statements of Work and Change Orders.
• Work closely with imaging and therapeutic area KOLs to accumulate medical and scientific knowledge necessary to support study designs proposed to potential and existing clients.
• In conjunction with the Senior Management team, evaluate strategies to expand the current business, and provide insights into business requirements to enable product and service development to drive science through innovation.
• Ensure scientific deliverables comply with GCP, ICH E6, 21 CFR Part 11, and Voiant SOPs, and oversee scientific process improvement, including authorship and maintenance of Science SOPs, work instructions, and controlled templates.
• Serve as scientific subject matter expert during sponsor audits and regulatory inspections.

Education & Experience

• Master’s degree or higher in a scientific, engineering, or healthcare discipline (e.g., medical imaging, imaging science, medical physics, biomedical engineering, biomedical science, neuroscience, radiology, or a related discipline); PhD, MD, or MD/PhD preferred.
• At least 8 years’ experience (12 years for candidates without a PhD, MD, or MD/PhD) in clinical research or medical imaging within a CRO, biopharmaceutical company, or medical imaging device company, including at least 5 years in the design, documentation development, or independent review of imaging studies in an imaging core lab, reading center, or imaging CRO, or in an imaging-focused scientific function within a biopharmaceutical or medical imaging device company.
• Demonstrated experience designing read paradigms or imaging study designs, either with sponsors or as a sponsor, and authoring or leading Independent Review Charters, Adjudication Charters, or equivalent study documents.
• Demonstrated expertise in imaging and in the application of disease-specific response criteria in independent central review (e.g., RECIST 1.1, iRECIST, RANO / RANO 2.0, Lugano).
• At least 5 years of people leadership experience, including management of scientific or medical staff and leaders, and leadership of globally distributed teams.
• Thorough understanding of the drug development regulatory process and requirements as they apply to imaging and its use in clinical trials, including GCP, ICH guidelines, and 21 CFR Part 11, as well as FDA and EMA guidance on imaging endpoints.
• Preferred experience with endpoint adjudication committees or clinical event adjudication.
• Preferred experience with advanced MRI techniques (e.g., perfusion, diffusion, or volumetric analysis).
• Preferred working familiarity with quantitative HRCT, nuclear medicine and PET, cardiopulmonary hemodynamic endpoints, and AI-assisted read tools.
• Preferred experience with departmental budget management and contributing to business growth.
• Ability to organize and manage multiple priorities.
• Excellent verbal and written communication skills, including precise controlled documentation for regulated environments.
• Strong presentation skills, including bid defense and governance settings.
• Ability to balance scientific rigor with commercial awareness of scope, timelines, and budget.
• Comprehensive health, vision, and dental insurance (FSA/HAS)
• EAP, Health Advocates, and Ancillary Benefits available
• Generous paid time off and holiday
• 401(K) with employer matching plan
• Paid employer life insurance, a voluntary life and disability insurance
• Tuition Reimbursement
• Ongoing training and development
• Internet allowance for remote workers