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Clinical Trial Manager (Cell Therapy)

Remote

Our Opportunity…

We're seeking a highly organized, collaborative, and experienced Clinical Trial Manager to oversee our early phase cell therapy oncology clinical trials (our first study is targeting metastatic melanoma).  In this brand new role, you’ll facilitate collaboration with internal and external study teams to ensure patient recruitment, timelines, quality standards, Good Clinical Practices and applicable regulations are being met throughout all stages of the study while developing Obsidian’s systems and practices. You will also contribute to further expansion of the team.    

As part of our Clinical team, you’ll play a vital role in achieving Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115 engineered to make TILs more effective for more patients. We need a hands on individual contributor who takes ownership and brings knowledge and experience to launch our new clinical studies, anticipate and mitigate risks, exercise good judgement, and help us build an excellent clinical operations practice.

This is a unique opportunity to be a contributor in a well-funded clinical 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.

You Will…

• Support all clinical aspects of clinical trial operations from site selection and qualification, through study initiation to close out ensuring study deliverables are met on time and all relevant metrics are tracked and reported.
• Contribute to the development of study execution plans, partner with internal and external teams (Regulatory Affairs, Program Management, CMC, CRO, investigators/site staff, specialty labs, etc.), identify and mitigate risk throughout the study lifecycle.
• Assist in development of study budget, review and approve clinical invoices, and oversee expenses to ensure all fall within approved budget.
• Oversee study start up and site initiation activities and ensure clinical research staff including CRO, CRAs, sites and other contract personnel receive study-specific training and leadership.
• Contribute to writing clinical protocols, study related documentation (ICF template, CRFs, CRF Completion Guidelines Monitoring Plan, Laboratory Manual, TMF plan, Pharmacy Manual, etc.) and regulatory documents such as INDs.
• Prepare and review site study documents (e.g. site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
• Ensure the Trial Master File (TMF) documentation is complete and up to date.
• Oversee laboratory sample management and ensure clinical supplies are available for sites.
• Participate in quality assurance activities (review of protocol deviations, site specific CGP issues, review of monitoring reports etc.) and ensure audit-ready condition of clinical trial documentation including central clinical files/Trial Master Files.
• Oversee clinical monitoring activities ensuring compliance with ICH/GCP and applicable regulations.
• Assist in developing and managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met.
• Prepare and present project briefings as required. Plan and facilitate study-specific meetings with CRO or other vendors (e.g., Study Management Meetings, investigator meetings, etc.).
• Participate in selection and management of external vendors, develop vendor specifications, and review vendor reports, budgets, and metrics.

You Bring…

Core Qualifications

• BS or BA degree in a life sciences field, plus 7+ years of relevant experience in clinical trial operations, including early phase trials.
• Cell or Gene therapy and Oncology experience is required, including an understanding of clinical supply logistics and sample management for cell therapy trials.
• Biotech/biopharma sponsor experience, including oversight of CROs in multi-site studies.
• Strong knowledge of ICH/GCP and regulatory requirements.
• Experience with clinical study data review and data management processes, including Data Monitoring, protocol deviations, and overall data integrity of studies.
• Demonstrated initiative, recognize gaps and opportunities for improvement and develop solutions.
• An ability to manage multiple responsibilities in parallel in a dynamic environment.
• Exceptional attention to detail, organization, and record-keeping.   
• Proven ability to work with general direction, exercise good judgement, and seek the information and support you need to meet objectives and timelines.
• A highly collaborative working style – you build trusting relationships, invite and share ideas and feedback, productively challenge your own and others’ assumptions to generate new ideas and facilitate better outcomes.
• Flexibility; a willingness and ability to adapt to changes in priorities in a fast-paced, rapidly developing environment in order to advance our mission.
• Scientific curiosity, and a track record of self-directed learning. 
• Ability to travel up to 20%.

 Bonus Qualifications

• Experience supporting regulatory filings, inspections, and audits.

Work location: Cambridge, MA (hybrid) or Remote

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