Director, Data Management

The Company: This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich’s ataxia. Friedreich’s ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. The company has between 60 and 70 employees and has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs). The company’s strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team’s know-how and expertise to the development of CTI-1601 and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Job Overview 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. Key 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 PI3269252a7307-25448-40328842