Director, Data Management

Larimar Therapeutics•Lower Merion Township, PA

About The Position

The Director, Data Management is a key leader within the Biometrics function, responsible for defining and executing the company’s clinical data strategy across programs. This is a high-impact, hands-on leadership role suited for a dynamic biotech environment, where building, scaling, and transforming data management capabilities is critical to success. This individual will lead end-to-end clinical data management activities, drive operational excellence, and ensure delivery of high-quality, inspection-ready data and documentation to support regulatory submissions, audits, and global health authority inspections.

Requirements

Bachelor’s or Master’s degree (or equivalent experience) in a scientific or related field
10+ years of progressive experience in clinical data management within biotech/pharma, CROs, or a combination of both
Demonstrated success supporting global clinical trials across multiple phases, including regulatory submissions, audits, and health authority inspections
Strong working knowledge of EDC systems, eCRF design, database development, data standards, and clinical data workflows
Proven ability to lead vendors/CROs and manage complex timelines across multiple programs
Deep understanding of GCP, ICH guidelines, and regulatory expectations for inspection readiness, data quality, and data integrity
Strategic thinker with the ability to operate hands-on and adapt to evolving priorities
Excellent communication and stakeholder management skills, with the ability to influence across functions and levels

Nice To Haves

Direct experience leading or supporting inspection readiness activities, including audit preparation, documentation review, and CAPA management strongly preferred
Experience building or transforming data management functions in a resource-constrained or fast-paced environment preferred

Responsibilities

Lead and scale the Data Management function, establishing vision, strategy, and execution plans aligned with company goals
Oversee all aspects of clinical data management from study start-up through database lock, reporting, and archiving, ensuring continuous inspection readiness across programs
Drive cross-functional collaboration with Clinical Development, Biostatistics, Regulatory, Quality, and external partners (e.g., CROs, vendors) to ensure seamless study execution and audit/inspection preparedness
Establish and maintain data management standards, processes, and infrastructure, including SOPs, work instructions, and best practices aligned with inspection readiness expectations
Provide oversight of key deliverables, including data management plans, edit check specifications, data validation processes, and database design (eCRFs), ensuring completeness, traceability, and auditability
Ensure data quality, integrity, and timeliness through effective data review, cleaning strategies, and metrics-driven oversight, with a focus on producing inspection-ready datasets
Lead and support inspection readiness activities, including preparation of documentation, participation in audits and regulatory inspections, and management of findings, CAPAs, and responses
Identify and implement process improvements, innovative technologies, and scalable solutions to enhance efficiency, quality, and inspection preparedness
Serve as a strategic partner to senior leadership, contributing to clinical development plans, regulatory strategy, and inspection readiness planning
Foster a culture of accountability, collaboration, continuous improvement, and inspection readiness mindset within the team and across functions