About Us
Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.
It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
Led by Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
These values are the foundation of our work, empowering us to make a real difference, every day.
Position Title: ED Clinical Data Management
Department: Development Operations & Biometrics
Reports To: VP, Biometrics
Location: Princeton, NJ – On-site 4 days per week (Mon to Thurs)
Job Overview
The Executive Director, Clinical Data Management, leads the strategic and operational direction of the Clinical Data Management function across the clinical development portfolio at Kardigan. Operating in a lean, faced-paced environment, the incumbent will lead the acquisition, management, and delivery of clinical data across all clinical programs and actively contribute to the clinical and regulatory strategy and submissions. Reporting to the VP of Biometrics, this role is a member of the Biometrics leadership team, and, as such, contributes to key initiatives and enterprise level projects.
Essential Duties and Responsibilities
- Set vision, oversee and direct the clinical data management function, including design and implementation of the clinical data management process, vendor selection & oversight, clinical systems design and validation, user acceptance testing, data integration and quality, data review, dictionary coding, data transfer, reporting, and archival activities for EDC, IRT, and other clinical systems
- Oversee integrated data strategies across programs and trials to ensure delivery of quality, inspection-ready datasets
- Develop and oversee key performance indicators, ensure continuous improvement, and risk & issue management
- Oversight of financial forecasting, budget, and expense management
- Ensure that all submitted data and information follow regulations (eg, ICH E6/E9, 21 CFR Part 11, GCP) and global data standards & regulatory requirements for NDA/BLA submission
- Serve as a liaison between Development, Regulatory, Pharmacovigilance, Research, IT, other stakeholders to ensure that data related business requirements are clearly defined, communicated, well understood, and considered as part of operational efficiency and strategic planning
- Champion modern automation and data visualization tools to improve efficiency and data quality
- Oversee standards for data acquisition, CDISC/CDASH compliance, data cleaning, query resolution, and overall data quality ready for regulatory submission
- Drive the selection and optimization of data systems (eg, EDC, data repositories) and scalable governance & SOP for data flow, data integrity, and oversight of CRO/vendor deliverables
- Design a future state clinical data management function transforming into an automated and ‘real time’ data function and reducing site & patient burden
- Drive the organization’s data-driven culture, enabling rapid, high-quality decision making through analytics and innovative data solutions
- Assess and transform capabilities through AI and Automation solutions or strategies with a focus on real-time data strategies to enable decision-making
- Establish best practices, SOPs, and governance frameworks for data flow across programs
- Conduct resource forecasting and talent development including training, mentoring, goal setting, performance management and engagement
- Lead or support the Health Authority inspections and audits as related to Data Management activities
- Up to 20 – 30% domestic and international travel as required
Qualifications and Preferred Skills
- Bachelor’s degree required. Advanced degree preferred (MS, PhD, MD, MPH) in Life Sciences, Data Science, Biomedical Engineering, Informatics, or related field.
- 12+ years of experience in Clinical Data Management, Clinical Operations or Biometrics within biopharma, biotech, CRO, or health technology. Or 10+ years with an advanced degree
- Experience leading teams across multiple locations and geographic regions preferred
- Preferred: Advanced training or certification in clinical research and/or data management relevant disciplines (PMP, CCDM, etc.)
- Preferred: Prior experience working in smaller, fast-paced company
- Extensive experience in drug development and working with regulatory agencies such as FDA and EMA
- Proficiency in CDISC requirements for regulatory submissions, including expertise with preparation and submission of data in CDISC - STDM/ADaM, CDASH
- Strong understanding of EDC systems, data standards, and end-to-end data management processes and governing regulatory expectations (ICH, 21CFR Part 11)
- Experience managing non-EDC data sourced (e.g laboratory data, imaging data, ePRO, IRT and other sources)
- Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required
- Excellent collaborator, communicator (verbal & written), and influencer across technical and non-technical audiences
- Detail and process oriented and demonstration of strong project management skills. Exhibits expertise in metrics analysis and reporting methodologies.
- Demonstrated success in leading high-performing, multidisciplinary teams