Executive Director, Clinical Data Management at Kardigan

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}">&nbsp;</span></p> <div data-olk-copy-source="MessageBody">Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.<br><br></div> <div>It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.</div> <div>&nbsp;</div> <div>Led by Tassos Gianakakos, Jay Edelberg, <span data-olk-copy-source="MessageBody">M.D., Ph.D.,</span> 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.</div> <div>&nbsp;</div> <div>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.</div> <div>&nbsp;</div> <div>At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. <strong>Driven by patients and their families</strong>, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in <strong>being authentic</strong>—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 <strong>eagerness to learn</strong>, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to <strong>winning as a team</strong> with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to <strong>enable the impossible</strong> because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.</div> <div>&nbsp;</div> <div>These values are the foundation of our work, empowering us to make a real difference, every day.</div> <div>&nbsp;</div> <div>&nbsp;</div></div><p><strong>Position Title:</strong><strong> </strong> ED&nbsp;Clinical Data Management<strong> </strong>&nbsp;</p> <p><strong>Department:</strong><strong> </strong> Development&nbsp;Operations &amp; Biometrics&nbsp;</p> <p><strong>Reports To:</strong><strong> </strong> &nbsp;VP, Biometrics&nbsp;</p> <p><strong>Location:&nbsp;</strong>Princeton, NJ&nbsp;– On-site 4 days per week (Mon to Thurs) &nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p><strong>Job Overview</strong> &nbsp;</p> <p>The Executive Director, Clinical Data Management,&nbsp;leads the strategic and operational direction&nbsp;of the&nbsp;Clinical&nbsp;Data&nbsp;Management&nbsp;function&nbsp;across the clinical development portfolio&nbsp;at&nbsp;Kardigan.&nbsp;Operating in a lean, faced-paced environment, the incumbent will&nbsp;lead&nbsp;the&nbsp;acquisition,&nbsp;management, and&nbsp;delivery&nbsp;of&nbsp;clinical data&nbsp;across all clinical programs and actively contribute to&nbsp;the&nbsp;clinical&nbsp;and&nbsp;regulatory strategy and submissions.&nbsp;Reporting to the&nbsp;VP&nbsp;of Biometrics, this role is a member of the Biometrics leadership team, and, as such, contributes to&nbsp;key initiatives and enterprise level&nbsp;projects.&nbsp;&nbsp;</p> <p><strong>Essential Duties and Responsibilities</strong> &nbsp;</p> <ul> <li>Set vision, oversee and direct the&nbsp;clinical&nbsp;data management function, including design and implementation of the clinical data management process,&nbsp;vendor selection &amp; oversight,&nbsp;clinical systems design&nbsp;and validation,&nbsp;user acceptance testing, data integration&nbsp;and quality, data review, dictionary coding, data transfer, reporting, and archival activities for EDC, IRT, and other clinical systems</li> <li>Oversee integrated data strategies across&nbsp;programs&nbsp;and trials&nbsp;to&nbsp;ensure delivery&nbsp;of quality, inspection-ready datasets </li> <li>Develop and oversee&nbsp;key performance indicators, ensure continuous improvement, and risk &amp; issue management</li> <li>Oversight of financial forecasting, budget, and expense management</li> <li>Ensure that all&nbsp;submitted&nbsp;data and information&nbsp;follow&nbsp;regulations (eg, ICH E6/E9, 21 CFR Part 11, GCP) and global data standards &amp;&nbsp;regulatory requirements for&nbsp;NDA/BLA&nbsp;submission&nbsp;</li> <li>Serve as a liaison between Development,&nbsp;Regulatory,&nbsp;Pharmacovigilance, Research,&nbsp;IT,&nbsp;other&nbsp;stakeholders to ensure that data related business requirements are clearly defined, communicated, well understood, and considered as part of operational efficiency and strategic planning</li> <li>Champion modern automation&nbsp;and data visualization tools to improve efficiency and data quality&nbsp;&nbsp;</li> <li>Oversee standards for data acquisition, CDISC/CDASH&nbsp;compliance, data cleaning, query resolution, and overall data quality ready for regulatory submission</li> <li>Drive the selection and optimization of data systems (eg, EDC, data repositories) and scalable governance &amp; SOP for data flow, data integrity, and oversight of CRO/vendor deliverables</li> <li>Design a future state clinical data management function transforming into an automated and ‘real time’ data function and reducing site &amp; patient burden</li> <li>Drive the organization’s data-driven culture, enabling rapid, high-quality decision making through analytics&nbsp;and&nbsp;innovative data solutions</li> <li>Assess and transform capabilities through AI and Automation solutions or strategies&nbsp;with a focus on real-time data strategies to enable decision-making</li> <li>Establish best practices, SOPs, and governance frameworks for data flow across programs</li> <li>Conduct resource forecasting and&nbsp;talent development&nbsp;including training, mentoring, goal setting, performance&nbsp;management&nbsp;and engagement</li> <li>Lead or support the Health Authority inspections and audits as related to Data Management activities</li> <li>Up to 20 – 30% domestic and international travel as&nbsp;required</li> </ul> <p><strong>Qualifications and Preferred Skills</strong> &nbsp;</p> <ul> <li>Bachelor’s&nbsp;degree&nbsp;required. Advanced degree preferred (MS, PhD, MD, MPH) in Life Sciences, Data Science, Biomedical Engineering, Informatics, or related&nbsp;field.</li> <li>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</li> <li>Experience leading teams across multiple locations&nbsp;and geographic regions&nbsp;preferred</li> <li>Preferred: Advanced&nbsp;training or certification in clinical research&nbsp;and/or data&nbsp;management&nbsp;relevant disciplines&nbsp;(PMP, CCDM, etc.)</li> <li>Preferred:&nbsp;Prior experience working in smaller,&nbsp;fast-paced company</li> <li>Extensive experience in drug development and working with regulatory agencies such as FDA and EMA </li> <li>Proficiency&nbsp;in&nbsp;CDISC requirements for regulatory submissions, including&nbsp;expertise&nbsp;with preparation and submission of data in&nbsp;CDISC -&nbsp;STDM/ADaM, CDASH&nbsp;</li> <li>Strong understanding of EDC systems, data standards, and end-to-end data management processes&nbsp;and governing regulatory expectations (ICH, 21CFR Part 11)</li> <li>Experience managing non-EDC data sourced (e.g&nbsp;laboratory data, imaging data, ePRO, IRT and other sources)</li> <li>Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are&nbsp;required </li> <li>Excellent&nbsp;collaborator, communicator (verbal &amp; written), and influencer across&nbsp;technical and non-technical audiences</li> <li>Detail and process oriented and demonstration of strong project management skills. Exhibits&nbsp;expertise&nbsp;in&nbsp;metrics&nbsp;analysis and reporting methodologies.</li> <li>Demonstrated&nbsp;success in leading high-performing, multidisciplinary teams </li> </ul> <p>&nbsp;</p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Exact Compensation may vary based on skills, experience and location.</p></div><div class="title">Pay range</div><div class="pay-range"><span>$258,000</span><span class="divider">&mdash;</span><span>$336,000 USD</span></div></div></div>