Director/Sr. Director, Clinical Data Management

Kelonia Therapeutics • Boston, MA

2d

About The Position

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. This role will oversee the planning, execution and quality assurance of clinical data management activities across the 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.

Requirements

• 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 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 and relevant regulatory requirements within the biopharmaceutical industry 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 Part 11, and global regulatory requirements
• Experience designing, standardizing and implementing data management strategies and standards for global development programs is required
• Experience in the management/oversight of CROs and other third-party vendors performing monitoring and DM activities is required
• Experience with all aspects of clinical trial conduct (startup through close-out) is required
• Prior demonstrated experience serving as a key leader to support organizational decision making and strategic planning required
• Understanding of drug development and program management from pre-IND through regulatory filing
• Demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required.
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Advanced skills in continuous improvement, project management, change management, and risk management.

Nice To Haves

• Experience in regulatory filings (e.g., IND, CTA, BLA) highly desired
• Previous involvement in the oversight and management of GCP regulatory inspections desired

Responsibilities

• Develop and implement comprehensive clinical data management strategies aligned with company objectives and regulatory requirements
• Provides strong leadership and inspiration to the DM function. Forecasts and manages resources needs, budget and timelines. Hires, develops, and retains talent. Responsible for the performance management of the DM function, including performance of outsourced data management activities.
• Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions work.
• Proactively identifies and manages risks for the DM function and supports functional risk identification/management efforts globally.
• Serves as the internal DM expert to provide strategic thinking for outsourcing strategy. Provides strategic leadership in DM related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.
• Serves as an expert accountable for robust DM processes (including but not limited to eCRF design, all steps from database development to database release, data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance
• Familiar and capable of integrating data visualization technologies like Spotfire or others for data review analysis and presentation. Using data visualization of metadata for reporting DM metrics.
• Capable of driving SAP and programming timelines to meet deliverables in collaboration with clinical operations, biostatistics and vendors
• Ensures that Data Management Plans are consistent and regulatory compliant across studies and programs.
• Serves as the DM leader during regulatory inspections and internal audits
• Ensures inspection readiness of all data management activities conducted internally or outsourced
• Represent 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.

Benefits

• Flexible Time Off
• flexible scheduling that aligns with your needs and our objectives
• a competitive benefits package (health, commuter, and more)
• great on-site perks that include free parking, a state-of-the-art gym, and a food hall
• a collaborative, inclusive team that invests in your development and makes big things happen together.

What This Job Offers

• Job Type: Full-time
• Career Level: Director