Obsidian Therapeutics

Clinical Trial Associate - Oncology

Obsidian Therapeutics$92K — $112K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • BS/BA/RN Degree with 3+ years in life sciences or health-related field preferred.
  • 1+ years in phase I-IV clinical studies in biopharmaceutical/biotech, CRO or academia.
  • Experience in oncology and/or cell therapy clinical trial operations is a plus.
  • Solid understanding of ICH/GCP and regulatory standards.
  • Excellent communication, planning, and time management skills.

Responsibilities

  • Support daily clinical trial operations aligning with protocols and regulatory standards.
  • Act as a coordination point among internal teams, CROs, and vendors.
  • Maintain Trial Master File (TMF) with a focus on accuracy and audit readiness.
  • Conduct TMF quality control and proactively resolve gaps.
  • Facilitate audits and inspections, ensuring thorough preparation and follow-up.

Benefits

  • Comprehensive medical, dental, and vision coverage.
  • Company contributions to health savings and retirement accounts.
  • Ample paid time off.
  • Access to wellness programs.
  • Rich opportunities for career growth.
Full Job Description
We are looking for a highly motivated Clinical Trial Associate, with a background in Oncology and/or Cell Therapy clinical trials. As a key contributor within Clinical Operations, you'll help drive the development of our first clinical stage autologous cell therapy trial targeting solid tumors. You'll play a key role in driving 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 a vital part of a highly collaborative organization working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy. This is a unique opportunity to be a contributor in a well-funded clinical stage company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. This is a Hybrid role based out of our Bedford, MA location. You Will... Core responsibilities 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 escalate 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. You Bring... Core Qualifications BS/BA/RN Degree with 3+ years of experience in a life science or a 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 managing multiple responsibilities in parallel. Flexible - adapts to change in a fast paced, rapidly developing environment Curious and humble - continuous learner, seeks and welcomes input/expertise of others Tenacious and resilient - is not easily overwhelmed by challenges, delivers on commitments, operates with urgency. Bonus Qualifications Proficiency in Microsoft Project or other project management programs. Obsidian is committed to equitable and transparent pay practices. The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role's location. Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role's level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities. Anticipated Base Salary Range $92,000-$112,500 USD

About Obsidian Therapeutics

Obsidian Therapeutics is a biotechnology company that develops cell and gene therapies for the treatment of various diseases. The company's proprietary cytoDRiVE platform enables precise control of protein expression in cells, allowing for the development of therapies with enhanced safety and efficacy. Obsidian's pipeline includes therapies for cancer, autoimmune diseases, and genetic disorders. The company was founded in 2015 and is headquartered in Cambridge, Massachusetts.
Learn more about Obsidian Therapeutics
Size
30 employees
Industry
Founded
2015
NASDAQ

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