Associate Director, Data Management at Obsidian Therapeutics

Cambridge or Bedford, MAFull-timeClinical OperationsPosted about 2 months ago

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 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 <ul> <li>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  </li> <li>Actively represent Data Management in study team meetings, leadership forums, and regulatory audits </li> <li>Provide expertise in database setup, CRF design, and development of data management strategy to ensure high-quality, submission-ready data  </li> <li>Develop data management plans (DMPs) and provide technical guidance on clinical database structures to internal teams and external partners  </li> <li>Ensure all clinical data, including AE and SAE data, complies with CDISC standards (CDASH/SDTM) and is prepared for FDA and EMA submissions  </li> <li>Oversee data cleaning, discrepancy management, and reconciliation of third-party data sources (e.g., central labs, IRT)  </li> <li>Collaborate with Programming to implement internal data quality checks and support ongoing data review activities  </li> <li>Partner with Clinical Operations, Biostatistics, Medical Monitoring, and Regulatory Affairs to define data standards, assess data quality, and resolve queries  </li> <li>Ensure integration of data across clinical and manufacturing systems, including specialized tracking such as scalpel-to-vein processes for TIL therapy  </li> <li>Manage vendors and ensure appropriate resourcing to support clinical trial execution  </li> <li>Coordinate CDM deliverables across internal and external cross-functional teams  </li> <li>Collaborate with Supply Chain and Logistics to oversee tracking of manufacturing data  </li> <li>Work with Standards, Quality, and Compliance teams to develop and implement data standards and drive continuous process improvement  </li> <li>Develop and refine standard operating procedures (SOPs)  </li> <li>Apply strong project management, organizational, and interpersonal skills to support successful study execution </li> <li>Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes  </li> <li>Self-motivated, with a proven ability to meet objectives and timelines, managing multiple responsibilities in parallel.    </li> <li>Flexible - adapts to change in a fast paced, rapidly developing environment  </li> <li>Curious and humble – seeks and welcomes input/expertise of others, continuous learner  </li> <li>Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments </li> </ul> You Bring... Core Qualifications <ul> <li>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). </li> <li>Experience: 6 - 8+ years of experience in clinical data management, including significant experience in oncology, and ideally in cell therapy. </li> <li>Systems: Proficiency in electronic data capture (EDC) systems, particularly Medidata Rave. </li> <li>Technical Knowledge: Strong understanding of CDISC, SDTM, CDASH, and ICH-GCP regulations. </li> <li>Leadership: Proven ability to manage CROs and lead cross-functional teams. </li> <li>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 with colleagues within the clinical team, across the Obsidian organization, and with external partners.   </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">$183,000—$223,500 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>

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