Director, Clinical Data Management
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
The Director, Clinical Data Management will be responsible for the leadership of the Clinical Data Management. This individual will manage the strategic and operational aspects of data management supporting clinical development activities across Kyverna programs, including oversight of data management contractors / vendor partners and management of external laboratory data. The position requires a detailed knowledge of data management platform and software, clinical trial databases, and pharmaceutical drug development process. The successful candidate will provide direction and guidance to the clinical development team and will be responsible for supporting end-to-end data management activities for multiple clinical studies.
Responsibilities
- Establish and provide leadership to the Data Management team by providing expertise and guidance to the clinical development team regarding data standards, data quality, validation, integration with regulatory requirements
- Author/review eCRFs, CCGs, and Data Management Plans. Assist as needed with clinical documents such as clinical protocols, Investigator Brochure updates, annual reports and status updates
- Oversee and/or provide clinical study level data management oversight of outsourced clinical trials including: project management, vendor management, coordination of internal reviews, and approval of deliverables. Review data analysis listings and report on performance and quality; review clinical data within studies and across programs for trend analysis
- Lead database design and production, ensuring that CROs, vendors and internal staff meet the required quality standards
- Act as liaison with CROs, third-party data vendors, and EDC vendors. Collaborate with the internal clinical study team to ensure all stakeholders’ needs are addressed and communicate project status and issues. Accountable for external data vendor documentation, management, and reconciliation
- Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines
- Contribute to project resource planning, re-forecasting, and program deliverable timeline
Requirements
- 10+ Years of Data Management experience
- Bachelor’s degree (or higher), Master’s preferred
- Experience implementing Clinical Data Management standards and procedures is required
- Experience in regulatory GCP inspections/audits is a plus
- Demonstrated ability to manage staff that delivers project goals for clinical data management and mentoring junior data managers
- Successfully manage clinical data management vendors, contractors and service providers
- Flexible and creative with changing priorities, and detail-oriented, with initiative to take on unfamiliar tasks
- Good analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
The salary range for candidates residing in California for this position is $184,000 USD to $260,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets