Description
Medical Research Scientist contributes to the day-to-day scientific support of studies. This function is accountable for working with the Clinical Operations, Commercial, and Global Services teams, as well as external readers, to ensure that scientific issues are appropriately considered in the development and execution of clinical studies.
Role & Accountabilities
- Provide scientific and technical expertise on implementing BICR strategies for clinical trials across Phase IIV.
- Author and contribute to independent review charters, imaging charters, read guidelines, reader training materials, and other scientific clinical trial documents.
- Research, evaluate, and implement novel read criteria. Stay current on relevant regulatory guidance (FDA, EMA, ICH), including FDA guidance on clinical trial imaging endpoint process standards, and apply it to study design and execution.
- Train and test independent reviewers. Train and mentor Voiant team members, including junior scientists.
- Act as the scientific point of contact for Clinical Operations, Data Management, Biostatistics, and QA. Resolve queries on image quality, read quality checks, and other scientific issues so projects are delivered efficiently.
- Work with the Technical Delivery, Innovation, and Data Management departments to define and review user and software requirements, and support user acceptance testing of analysis systems and criteria-related checks.
- Review study data and prepare reports to monitor reviewer performance, including variability, adjudication rates, and emerging trends. Recommend corrective actions or retraining where needed.
- Contribute to the development of internal standards and SOPs, and make sure they are applied consistently across studies.
- Work closely with KOLs to build the medical and scientific knowledge that supports study designs proposed to potential and existing clients.
- Support science-related business development, including scientific content for proposals, bid defenses, and pricing of science and reader activities.
- Represent Voiant at investigator meetings, client meetings, and industry conferences, and contribute to publications and abstracts.
Education & Experience
- A bachelors degree in a science or healthcare discipline with 5 or more years of related experience may be considered in lieu of an advanced degree Advanced degree (MS, PhD, PharmD, or MD) in a preferred science or healthcare discipline.
- At least 3 years of clinical research experience within a CRO or pharmaceutical company, including experience in an imaging core laboratory or BICR environment.
- Background with good medical knowledge and experience in clinical development/operationsDemonstrated understanding of the BICR process, including common review paradigms, reader and adjudicator workflows, eCRFs, and key documents such as Independent Review Charters.
- Working knowledge of established and emerging efficacy and safety read criteria (for example, RECIST 1.1, iRECIST, RANO, Lugano, and other disease-specific grading criteria), and of primary, secondary, and exploratory endpoints and their value to sponsors.
- Technical understanding of imaging modalities (CT, MRI, X-ray, PET, SPECT, US) and awareness of emerging technologies such as PET-MRI and fMRI.
- Track record of authoring scientific documents and presenting at scientific meetings or conferences.
- Experience advising on quality assurance and data integrity to maintain GCP, 21 CFR Part 11, and regulatory compliance, including troubleshooting site-level issues.
- Experience acting as a subject matter expert within cross-functional clinical development teams.
- Strong analytical skills, with a focus on delivering high-quality results on time.
- Excellent written verbal, and presentation skills.
- Able to manage multiple projects under tight deadlines with a proactive, flexible approach.
- Confident working with internal teams, sponsors, KOLs, and other external partners.
