Senior Clinical Trial Associate - Oncology

obsidiantherapeutics

BedfordHybrid2w ago

Seniority: Senior

About the role

<div class="content-intro">About Us… Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program 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 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 the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA.   Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.</div>Our Opportunity... We are looking for a highly motivated Senior Clinical Trial Associate, with a background in oncology clinical trials. As a key contributor within Clinical Operations, you’ll help to 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 <ul> <li>Execute and support day-to-day clinical trial operations in alignment with protocols, timelines, and regulatory requirements. </li> <li>Serve as a key point of coordination across internal teams, CROs, and external partners. </li> <li>Maintain and oversee the Trial Master File (TMF), ensuring completeness, accuracy, and audit readiness. </li> <li>Lead TMF quality control activities and proactively address gaps. </li> <li>Support audits and inspections, including preparation and follow-up activities. </li> <li>Coordinate and oversee vendors, including central labs and specialty service providers. </li> <li>Manage biospecimen tracking, logistics, and associated documentation. </li> <li>Monitor vendor performance and escalate issues as needed. </li> <li>Develop, maintain, and improve study tracking tools (e.g., enrollment, sample tracking, timelines). </li> <li>Ensure data accuracy and timely reporting across study activities. </li> <li>Contribute to improvements in clinical operations processes and systems. </li> <li>Drive clear, timely communication across study teams and stakeholders. </li> <li>Plan and facilitate study meetings, including agenda development, minutes, and follow-up actions. </li> <li>Maintain version control and documentation across clinical materials. </li> <li>Support invoice tracking, purchase order coordination, and budget-related activities. </li> </ul> You Bring... Core Qualifications <ul> <li>BS/BA/RN Degree with 6+ years of experience in a life science or a health-related field is preferred. </li> <li>3+ years working on phase I-IV clinical studies within a biopharmaceutical/biotech, CRO, or academic environment. </li> <li>Experience and understanding of clinical trial operations, preferably in oncology and/or cell therapy space. </li> <li>Solid knowledge of ICH/GCP and regulatory requirements. </li> <li><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"Calibri",469777842,"Arial",469777843,"Calibri",469777844,"Calibri",201341986,"1",469769226,"Calibri,Arial",268442635,"22",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">Excellent planning, coordination, and time management skills   </li> <li>Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.   </li> <li>Ability to build and maintain productive relationships at all levels within and across internal teams, and with external partners.   </li> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"Calibri",469777842,"Arial",469777843,"Calibri",469777844,"Calibri",201341986,"1",469769226,"Calibri,Arial",268442635,"22",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes </li> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1">Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.   </li> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1">Flexible - adapts to change in a fast paced, rapidly developing environment  </li> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1">Curious and humble – continuous learner, seeks and welcomes input/expertise of others </li> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1">Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency. </li> </ul> Bonus Qualifications <ul> <li>Proficiency in Microsoft Project or other project management programs.</li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description">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.</div><div class="title">Anticipated Base Salary Range</div><div class="pay-range">$108,000—$132,000 USD</div></div></div><div class="content-conclusion">Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.</div>

Perks & benefits

Vision Insurance
Paid Time Off
Equity Compensation

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