Senior Director – Science
About the role
Remote - USA Job Description 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
- 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