Position Summary:TScan is seeking a highly motivated and detail-oriented Clinical Scientist with deep expertise in clinical data management and data review to support the execution of our oncology cell therapy clinical programs. This unique role sits at the intersection of Clinical Development, Clinical Operations, Data Management, and Biostatistics serving as a critical driver of data quality, data integrity, and clinical insight generation.
The Clinical Scientist will be responsible for leading ongoing clinical data review activities, developing data review strategies, identifying and resolving data issues, and ensuring high-quality clinical datasets are available to support safety reviews, regulatory submissions, and clinical decision-making. The successful candidate will possess a strong scientific background combined with hands-on experience in clinical data management, EDC systems, data visualization tools, and cross-functional collaboration.
This position offers an opportunity to play a highly visible role in advancing innovative TCR-T therapies through clinical development while helping establish best-in-class data review and clinical science processes.
Key ResponsibilitiesClinical Data Review & Oversight- Serve as the clinical lead for ongoing data review activities across TScan clinical studies.
- Develop and execute comprehensive data review plans to ensure timely identification and resolution of data discrepancies, trends, and potential safety signals.
- Review patient-level clinical data to assess completeness, consistency, protocol compliance, and medical relevance.
- Partner with Clinical Operations, Data Management, Medical, Pharmacovigilance, and Biostatistics to drive data quality and readiness.
- Lead cross-functional data review meetings and track resolution of key data issues.
Clinical Science & Data Interpretation- Analyze and interpret emerging clinical, safety, efficacy, and biomarker data to support study conduct and decision-making.
- Support data cleaning efforts for interim analyses, data monitoring committee reviews, and regulatory submissions.
- Contribute to clinical narratives, safety analyses, data listings review, and study reports.
- Collaborate with translational and biomarker teams to integrate clinical and correlative data insights.
Data Management Collaboration- Partner closely with Data Management to review CRFs, edit checks, data validation plans, and data review specifications.
- Provide clinical input into database design, study builds, and data collection strategies.
- Support UAT testing of EDC systems and associated clinical technologies.
- Review data transfer specifications and external vendor data integration processes.
- Ensure data review activities align with CDISC standards and regulatory expectations.
Clinical Development Support- Contribute to protocol development, endpoint definitions, and data collection strategies.
- Participate in study team meetings and provide clinical science expertise throughout study execution.
- Support preparation of clinical study reports (CSRs), regulatory documents, investigator brochures, and publications.
- Assist with inspection and audit readiness activities.
Process Improvement & Innovation- Develop and implement innovative approaches for ongoing clinical data surveillance and risk-based data review.
- Leverage data visualization tools and analytics platforms to enhance clinical data review efficiency.
- Contribute to the development of clinical data review SOPs, work instructions, and best practices.
- Help establish scalable processes to support growth of TScan's clinical portfolio.
QualificationsEducation- Advanced degree (PharmD, PhD, MS, MPH, or equivalent) in a life sciences, clinical research, or related field preferred.
- Bachelor's degree with significant relevant experience may be considered.
Experience- 5-8+ years of experience in clinical development, clinical science, data management, or related functions within biotechnology, pharmaceutical, or CRO environments.
- Demonstrated experience performing ongoing clinical data review in oncology or advanced therapy clinical trials.
- Experience working closely with Data Management and Biostatistics teams.
- Experience supporting early- and/or late-stage clinical trials.
- Oncology, immuno-oncology, cell therapy, CAR-T, TCR-T, or hematology experience strongly preferred.
Technical Skills- Strong understanding of clinical trial conduct, GCP, ICH guidelines, and regulatory requirements.
- Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva EDC, Oracle Inform).
- Experience using clinical data review and visualization tools such as Spotfire, Tableau, JReview, SAS, or similar platforms.
- Familiarity with CDISC standards (SDTM, ADaM) and clinical database structures.
- Strong analytical and problem-solving skills with the ability to interpret complex clinical datasets.
- Understanding of external data sources, including laboratory, imaging, biomarker, and pharmacokinetic data.
Leadership & Collaboration Competencies- Strong scientific curiosity and attention to detail.
- Ability to synthesize complex clinical data into actionable insights.
- Excellent communication and presentation skills.
- Proven ability to work effectively in highly cross-functional teams.
- Comfortable operating in a fast-paced, evolving biotechnology environment.
- Strong organizational skills with the ability to manage multiple priorities simultaneously.
