Job Description

Position Summary:

TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. The Clinical Scientist will play a key role in the design, execution, and analysis of clinical trials, working closely with Clinical Development, Medical Affairs, Biostatistics, and Regulatory teams. This individual will provide scientific and clinical expertise to ensure the successful execution of cell therapy trials from early-phase studies to registrational programs and long-term follow-up. A team player with a sense of urgency will thrive in this role.

This is an on-site role with some hybrid flexibility.

Responsibilities:

• Assist in the design and development of clinical trial protocols, investigator brochures, and clinical development plans.
• Support the execution of Phase 1 through registrational and long-term follow-up trials, ensuring adherence to regulatory and scientific standards.
• Collaborate closely with Medical Monitors to assess safety data, adverse events, and patient responses.
• With medical, biostats and programming, analyze clinical trial data and contribute to the interpretation of efficacy and safety results and ongoing trial optimization.
• Support regulatory submissions (INDs, BLAs, NDAs, and MAAs) by preparing clinical data summaries and responses to regulatory authorities (FDA, EMA, etc.).
• Assist in the development of clinical trial endpoints, biomarkers, translational and real world evidence (RWE) research strategies, and the integration of these data sources for analysis (external labs, transplant registries, etc).
• Contribute to the creation of scientific publications, abstracts, and presentations for congresses and peer-reviewed journals.
• Work closely with Clinical Operations to ensure protocol adherence, patient safety, and data integrity; as well as optimizing enrollment forecasts and site selection.
• Support the development and implementation of long-term follow-up strategies for patients receiving cell therapy treatments.
• Engage with key opinion leaders (KOLs), investigators, and clinical trial sites to gather insights and improve trial execution.
• Perform exploratory data analysis (EDA) and build data visualizations to identify trends in patient responses, safety profiles, and long-term outcomes.
• Assist in building predictive algorithms for GvHD risk, relapse, and transplant-related mortality (TRM) in cell therapy and bone marrow transplant patients.
• Support regulatory submissions (FDA, EMA, etc.) by generating high-quality data summaries, risk models, and validation reports.
• Collaborate with data management and programming to ensure accurate data cleaning, transformation, and mapping to CDISC standards (SDTM, ADaM).
• Develop (or work with DM/programming) to develop interactive dashboards (e.g., using Python, R, Tableau, or Spotfire) for real-time clinical data monitoring.
• Ability to develop and apply statistical models, machine learning, and AI-driven analytics to clinical trial and real-world data is a plus
• Knowledge and ability to visualize complex data using most up-to-date methods is a plus

Requirements:

• Master’s w/ 7+ or Ph.D. with 3+ or equivalent in Data Science, Biostatistics, Immunology, Computational Biology, Epidemiology, or a related field
• 3-5+ years of experience in clinical data science, clinical development, biostatistics, or clinical analytics in the biotech, pharma, or CRO industry.
• Expertise in R, Python, or SAS for data analysis, machine learning, and statistical modeling.
• Experience working with bone marrow transplant, hematologic malignancies, or cell therapy clinical trials is a strong plus.
• Knowledge of real-world evidence (RWE) generation, registry data, and biomarker-driven analytics.
• Experience with electronic data capture (EDC) systems such as Medidata Rave, Oracle InForm, or Veeva Vault.
• Strong understanding of GCP, ICH guidelines, CDISC (SDTM, ADaM), and regulatory compliance.
• Ability to work independently in a fast-paced biotech environment while collaborating cross-functionally.
• For applicants with exceptional and relevant skills and experience, some qualifications may be waived.

About TScan:

TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan’s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women’s Hospital and Harvard Medical School. TScan’s transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases.

Do YOU have the anatomy of a TScanner?

Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today.

EEO Statement

TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter.

Recruitment & Staffing Agencies

TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.

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