Our Opportunity…

We are looking for a strategic and hands-on Associate Director, IT Operations to lead and optimize Digital Solutions & Technology operations at Obsidian, delivering secure, compliant, and scalable technology services that enable our clinical-stage biotech teams to achieve breakthrough scientific and business outcomes.

You Will...

• Develop and execute Digital Solutions & Technology operations strategy aligned with Obsidian’s growth, compliance needs, and culture. 
• Lead day-to-day operations, including infrastructure, cloud environments, enterprise systems, and lab/scientific software. 
• Manage MSP resources, ensuring high-quality support and service levels. 
• Partner with Info Security lead to ensure robust cybersecurity and data protection. 
• Optimize Digital Solutions & Technology processes (incident, problem, change management) and drive adoption of best practices, with a strong emphasis on ITIL and change management in a controlled, regulated environment. 
• Manage vendor relationships and operations budget. 
• Support onboarding/offboarding, access management, and end-user training. 
• Foster a culture of accountability, collaboration, and continuous improvement. 
• Risk Management & Business Continuity: Identify, assess, and mitigate IT risks; develop and maintain business continuity and disaster recovery plans. 
• Work closely with Facilities, Lab Operations, and other business units to ensure Digital Solutions meet evolving scientific and operational needs. 
• Continuous Improvement & Innovation: Drive process optimization and adoption of new technologies to improve service delivery and operational efficiency. 
• KPIs & Metrics: Define, track, and report on IT operational KPIs (e.g., uptime, ticket resolution, user satisfaction, compliance metrics). 
• Regulatory Audit Readiness: Prepare for and support regulatory audits (FDA, SOX, etc.), ensuring documentation and processes are audit-ready. 

Key Systems & Platforms 

• Networking: Cisco Meraki, Fortinet 
• Scientific/Lab: Benchling, Egnyte 
• HR: ADP, Greenhouse, Pave 
• Finance: NetSuite, FloQast, Concur 
• Business Development: DataSite DataRooms 
• Enterprise: M365, Adobe, Teams, Teams Room Systems 
• Ticketing: Freshdesk 
• Compliance: ComplianceWire, validated SharePoint 

 You Bring...

Core Qualifications

• Bachelor's degree in computer science, Information Technology, or related field with 10+ years of relevant IT experience, including leadership of IT operations in a regulated environment (biotech, pharma, or healthcare preferred). 
• Experience with IT operations in agile, fast-growing companies. 
• Experience with GxP systems operational support (CSV/CSA). 
• Experience with change control systems and processes for GxP/SOX. 
• Experience managing MSPs and IT service delivery across multiple locations. 
• Strong knowledge of enterprise platforms (NetSuite, M365, ADP, Benchling, etc.) and lab/scientific software. 
• Experience managing Lab IT systems 
• Excellent planning, coordination, and time management skills. 
• Strong oral, written, and visual communication skills. 
• Ability to build productive relationships across scientific, business, and technical teams. 
• Systems thinking and sound judgment, especially in risk management and escalation 
• 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 and timelines, managing multiple responsibilities in parallel.   
• Flexible - adapts to change in a fast paced, rapidly developing environment 
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner 
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments  

Our Opportunity...

We are looking for a highly motivated Associate Director of Data Management. As a key contributor within the Clinical Operations team, you’ll be responsible for leading the entire data lifecycle at the program level for development of our first clinical stage autologous cell therapy program targeting solid tumors. 

You will be responsible from study startup to database lock for multiple clinical studies developing engineered TIL cell therapies for certain solid tumor indications, oversee end-to-end clinical data strategy, ensuring high-quality, regulatory-compliant data (e.g., SDTM/CDISC) from study startup to lock. 

You will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by collaboratively 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 company with blue chip investors, field-leading advisors, 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 Bedford or Cambridge, MA locations.  

You Will...

Core responsibilities

• Manage all clinical data management (CDM) activities, serving as the primary point of contact for CROs and vendors, ensuring studies are delivered on time, within budget, and in compliance with ICH-GCP  
• Actively represent Data Management in study team meetings, leadership forums, and regulatory audits 
• Provide expertise in database setup, CRF design, and development of data management strategy to ensure high-quality, submission-ready data  
• Develop data management plans (DMPs) and provide technical guidance on clinical database structures to internal teams and external partners  
• Ensure all clinical data, including AE and SAE data, complies with CDISC standards (CDASH/SDTM) and is prepared for FDA and EMA submissions  
• Oversee data cleaning, discrepancy management, and reconciliation of third-party data sources (e.g., central labs, IRT)  
• Collaborate with Programming to implement internal data quality checks and support ongoing data review activities  
• Partner with Clinical Operations, Biostatistics, Medical Monitoring, and Regulatory Affairs to define data standards, assess data quality, and resolve queries  
• Ensure integration of data across clinical and manufacturing systems, including specialized tracking such as scalpel-to-vein processes for TIL therapy  
• Manage vendors and ensure appropriate resourcing to support clinical trial execution  
• Coordinate CDM deliverables across internal and external cross-functional teams  
• Collaborate with Supply Chain and Logistics to oversee tracking of manufacturing data  
• Work with Standards, Quality, and Compliance teams to develop and implement data standards and drive continuous process improvement  
• Develop and refine standard operating procedures (SOPs)  
• Apply strong project management, organizational, and interpersonal skills to support successful study execution 
• 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 and timelines, managing multiple responsibilities in parallel.    
• Flexible - adapts to change in a fast paced, rapidly developing environment  
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner  
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments 

You Bring...

Core Qualifications

• Education: Bachelor's Degree in life sciences, mathematics, or related field; with 10+ years of progressive experience in a biopharma setting, or a master's degree with 8+ (Master’s preferred). 
• Experience: 6 - 8+ years of experience in clinical data management, including significant experience in oncology, and ideally in cell therapy. 
• Systems: Proficiency in electronic data capture (EDC) systems, particularly Medidata Rave. 
• Technical Knowledge: Strong understanding of CDISC, SDTM, CDASH, and ICH-GCP regulations. 
• Leadership: Proven ability to manage CROs and lead cross-functional teams. 
• 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 with colleagues within the clinical team, across the Obsidian organization, and with external partners.   

Join the Obsidian Therapeutics Talent Community

Are you interested in becoming part of our dynamic, innovative, passionate, collaborative, and dedicated team focused on engineering precision cell and gene therapies, but not seeing a specific opportunity that matches your interests or experience?  We'd still love to hear from you!  Please share your resume, tell us why you're interested in Obsidian, and the type of role you're looking for next.  We'll add you to our talent community and be able to consider your experience and interest when new opportunities arise.  

We look forward to hearing from you and staying in touch regarding upcoming opportunities!