Clinical Trial Associate - Oncology

About Us

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Our programs apply cytoDRiVE® technology in cell and gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Our lead program, OBX‑115, a novel engineered tumor‑infiltrating lymphocyte (TIL) therapy, is currently in clinical development for the treatment of patients with metastatic melanoma and non‑small cell lung cancer.

We’re proud of our diverse, talented team and are committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our research team is based in Cambridge, MA, and our technical operations team operates from a purpose‑built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

We are looking for a highly motivated Clinical Trial Associate with a background in oncology and/or cell‑therapy clinical trials. You will be a key contributor within Clinical Operations, helping to drive the development of our first clinical‑stage autologous cell therapy trial targeting solid tumors. You’ll play a vital role in the operational execution of complex clinical trials, supporting cross‑functional coordination, vendor oversight, and ensuring high‑quality, inspection‑ready study delivery.

As a member of our Clinical Operations Team, you will be part of a highly collaborative organization working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients, beginning with our lead program OBX‑115.

This is a hybrid role based out of our Bedford, MA location.

• Support day‑to‑day clinical trial operations in alignment with protocols, timelines, and regulatory requirements.
• Serve as a point of coordination across internal teams, CROs, and external partners.
• Maintain the Trial Master File (TMF), ensuring completeness, accuracy, and audit readiness.
• Perform TMF quality control activities and proactively address gaps.
• Support audits and inspections, including preparation and follow‑up activities.
• Coordinate with vendors, including central labs and specialty service providers.
• Support biospecimen tracking, logistics, and associated documentation.
• Track and monitor vendor performance and escalates issues as needed.
• Develop, maintain, and improve study tracking tools (e.g., enrollment, sample tracking, timelines).
• Ensure data accuracy and timely reporting across study activities.
• Contribute to improvements in clinical operations processes and systems.
• Facilitate clear, timely communication across study teams and stakeholders.
• Coordinate study meetings, including agenda development, minutes, and follow‑up actions.
• Maintain version control and documentation across clinical materials.
• Support invoice tracking, purchase order coordination, and budget‑related activities.

• BS/BA/RN degree with 3+ years of experience in a life science or health‑related field is preferred.
• 1+ years working on phase I‑IV clinical studies within a biopharmaceutical/biotech, CRO, or academic environment.
• Experience and understanding of clinical trial operations, preferably in oncology and/or cell therapy space.
• Solid knowledge of ICH/GCP and regulatory requirements.
• Excellent planning, coordination, and time‑management skills.
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.
• Ability to build and maintain productive relationships at all levels within and across internal teams, and with external partners.
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes.
• Self‑motivated, with a proven ability to meet objectives, timelines, and high standards while managing multiple responsibilities in parallel.
• Flexible – adapts to change in a fast‑paced, rapidly…