Associate Director, Data Management

Obsidian Therapeutics

18h•Hybrid

About The Position

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.

Requirements

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.

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