Director​/Sr. Director, Clinical Data Management

Here at Kelonia Therapeutics, we aren’t just a clinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we’re dreamers on a mission to bring the promise of cell and gene therapy to every patient in need.

We’ve gathered a group of pioneers in cell and gene therapy to lead our journey, with extraordinary scientific founders at the helm, providing the cutting‑edge technology that sets us apart. We’re not just building a company;
we’re cultivating a culture that values both skill and care
.

Are you ready to be a part of our remarkable journey? We’re looking for someone exceptional to join our growing team as a Director/Senior Director, Clinical Data Management in the Clinical group. This person is responsible for setting the vision, direction, and strategy for Data Management (DM) across our clinical development portfolio. The role will oversee the planning, execution and quality assurance of clinical data management activities across our clinical development programs, ensuring regulatory compliance and data integrity throughout the product development lifecycle.

This isn't just a job; it’s an opportunity to contribute to groundbreaking therapies, to be part of a company’s inception, and to make a transformative impact on patients' lives. If you’re passionate about scaling a company from the ground up, making a real difference, and shaping the inclusive culture we’re proud of, this opportunity is tailor-made for you. Join us and be a driving force in achieving excellence in viral engineering.

• Develop and implement comprehensive clinical data management strategies aligned with company objectives and regulatory requirements.
• Provide strong leadership and inspiration to the DM function. Forecast and manage resources, budgets, and timelines. Hire, develop, and retain talent. Oversee the performance management of the DM function, including outsourced data management activities.
• Collaborate within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions work.
• Proactively identify and manage risks for the DM function and support global risk identification and management efforts.
• Serve as the internal DM expert to provide strategic thinking for outsourcing strategy. Provide strategic leadership in DM related topics and establish the oversight model for timely and quality delivery of outsourced activities.
• Act as an expert accountable for robust DM processes (including eCRF design, database development to release, data review and cleaning, database lock) to ensure data quality, integrity, and regulatory compliance.
• Integrate data visualization technologies like Spotfire or others for data review, analysis, and presentation. Use data visualization of metadata for reporting DM metrics.
• Drive SAP and programming timelines to meet deliverables in collaboration with clinical operations, biostatistics, and vendors.
• Ensure that Data Management Plans are consistent and regulatory compliant across studies and programs.
• Lead as the DM representative during regulatory inspections and internal audits.
• Ensure inspection readiness of all data management activities conducted internally or outsourced.
• Represent the function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc., to identify industry best practices and increase the visibility of Kelonia Therapeutics.

• Advanced degree (MS/PhD) in Life Sciences, Statistics, Computer Science, or related field, or BS with equivalent experience.
• Minimum 12 years of clinical data management experience in the pharmaceutical/biotech industry, including 6+ years of leadership experience managing clinical data management teams and/or vendors.
• Advanced knowledge and experience working on global clinical trials (Phase I-IV) and diverse regulatory requirements across multiple therapeutic areas, including multiple myeloma, lymphoma, CAR‑T Therapy.
• Deep expertise with EDC systems (Medidata Rave preferred) and clinical data standards (CDISC/SDTM/ADaM).
• Strong knowledge of GCP, 21 CFR…