Associate Director, Clinical Data Management

About the role

Associate Director, Clinical Data Management

Prime Medicine is a biotechnology company focused on gene editing therapies. The organization utilizes a proprietary platform called Prime Editing to develop treatments intended to address genetic conditions. The platform is designed to target specific locations within genes with the goal of minimizing off-target effects. Therapeutic programs are advancing through several stages of research and development.

The company is seeking an Associate Director of Clinical Data Management to manage data activities for gene editing initiatives. This position is responsible for data strategy and execution across early-stage development through later-stage regulatory processes. The role involves oversight of data management for programs in the United States and internationally.

This position is based in Watertown, Massachusetts. It is a full-time role with an expected on-site work arrangement. The estimated compensation range is $150,000.00 to $180,000.00 annually.

Position Responsibilities

The Associate Director of Clinical Data Management will lead clinical data strategies for gene editing projects. This includes planning and execution from initial human studies through regulatory approval. The role requires developing data management plans that meet regulatory expectations for domestic and international submissions.

Responsibilities cover the full data collection cycle. This includes designing case report forms, building databases, creating edit checks, conducting data reviews, and managing data coding. The role ensures compliance with CDISC standards, including SDTM and ADaM datasets. It also involves maintaining documentation to support regulatory inspections and audits.

The position provides oversight for external partners. This includes selecting and managing contracts research organizations and data management vendors. The role manages vendor budgets, timelines, and performance metrics. It also coordinates external data transfers, such as serious adverse event information, laboratory results, pharmacokinetic and pharmacodynamic data, and reconciliations. The role ensures that change control procedures, database archiving, and data governance practices are documented and followed.

Given the focus on gene therapy, the role requires managing complex data streams. This includes genomic and sequencing information, biomarker data, pharmacokinetic and pharmacodynamic measurements, and immunogenicity results. The position supports dose-escalation studies with rapid turnaround times for data review. It prepares study materials for Data Monitoring Committee and Safety Review Committee assessments. The role adapts data management processes to the specific needs of rare disease studies, including small patient populations and adaptive trial designs.

The role contributes to the development of data infrastructure. This includes identifying opportunities to improve efficiency across programs. It supports the implementation and optimization of electronic data capture, electronic patient-reported outcome tools, and interactive response technology systems. The role ensures integration between clinical data, laboratory systems, and sample tracking platforms.

The Associate Director collaborates with multiple internal functions. This includes working with clinical development, clinical operations, regulatory affairs, quality assurance, and translational science teams. The role acts as a subject matter expert for cross-functional initiatives. It establishes standards for Data Monitoring Committee readiness. This includes creating rapid data review cycles specific to gene editing studies.

Qualifications

Candidates must have direct experience managing data for gene therapy or rare disease clinical programs. They must show a thorough understanding of CDISC standards, particularly SDTM and ADaM, for regulatory submissions. A track record of managing vendor selection, performance, and budget oversight for CROs is required.

The candidate must have a history of maintaining audit-ready documentation. This includes robust change control procedures and version management practices. Experience managing complex biologic or genome editing trials is necessary. This includes trials with adaptive designs and multi-cohort structures.

Additional Information

The job description outlines the primary responsibilities and qualifications for this position. It is intended for informational purposes only. Details regarding the application process and specific requirements will be available on the official career portal.