Job Description

Prime Medicine is seeking an experienced Associate Director of Clinical Data Management to lead clinical data strategy and execution across gene editing programs from first-in-human studies through regulatory submission. This role will oversee all internal and external data management activities supporting INDs, CTAs, BLAs, and global regulatory filings.

The ideal candidate has experience in rare disease clinical trials, vendor oversight, and complex biologic or gene therapy programs, and is comfortable operating in a fast-paced environment. This individual will ensure clinical data integrity, regulatory readiness, and high-quality execution across the development portfolio.

This role reports to the Senior Director, Clinical Operations.

Key Responsibilities

Clinical Data Leadership

• Lead all clinical data management activities across multiple programs from IND through BLA submission.
• Develop and execute data management strategies aligned with regulatory requirements both in the US/ex-US
• Oversee CRF design, database build, edit checks, data review, coding, reconciliation, and database lock.
• Ensure implementation of CDISC standards (SDTM/ADaM) to support submission readiness.
• Support inspection readiness and maintain audit-ready documentation.

Vendor Oversight & Governance

• Lead selection, oversight, and performance management of CRO and data management vendors.
• Manage vendor budgets, timelines, KPIs, and quality metrics.
• Oversee external data transfers and reconciliation processes (e.g., SAE, lab, PK and PD).
• Ensure change control, database archiving, and data governance processes are compliant and well documented.

Gene Therapy & Rare Disease Expertise

• Oversee integration of complex data streams including:
• Genomic and sequencing data
• Biomarker and translational endpoints
• Immunogenicity and PK/PD
• Long-term follow-up safety data
• Support dose-escalation studies with rapid data review cycles and SRC/DMC readiness
• Tailor data processes to rare disease trial realities (small populations, adaptive designs, multi-cohort studies).

Systems & Infrastructure

• Contribute to scalable data infrastructure and identification of key efficiencies between programs
• Support implementation and optimization of EDC, ePRO, IRT, and data visualization systems.
• Ensure integration between clinical data, laboratory systems, and sample tracking systems.

Cross-Functional Collaboration

• Partner with Clinical Development, Clinical Operations, Regulatory, Quality, and Translational Sciences.
• Serve as subject matter expert for data standards, governance, and process improvement initiatives.
• Contribute to development and improvement of internal SOPs and workflows.

Qualifications

• Bachelor’s degree in life sciences, statistics, informatics, or related field (advanced degree preferred).
• 8+ years of progressive clinical data management experience, including leadership responsibility.
• Experience supporting IND submissions and major regulatory filings (BLA/NDA/MAA).
• Direct experience in rare disease and/or gene therapy, gene editing, or advanced biologics strongly preferred.
• Demonstrated CRO/vendor oversight experience in global trials.
• Strong knowledge of ICH/GCP, FDA/CFR regulations, CDISC standards, and eCTD submission requirements.
• Experience with EDC systems, medical coding (MedDRA/WHO Drug), and external data integration.
• Strong understanding of safety data reconciliation and regulatory inspection preparedness.
• Excellent organizational, project management, and communication skills.

Key Competencies

• Strategic thinker with strong execution skills.
• Detail-oriented with high standards for data quality and compliance.
• Collaborative and cross-functional mindset.
• Comfortable working in a dynamic, innovative biotech environment.
• Passion for advancing transformative therapies for patients with rare genetic diseases.