Executive Director, Head of Global Site ManagementPrinceton, New JerseyKardigan 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 Gianakakos, 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.The Head of Global Site Management leads all site-facing clinical trial activities across the global development portfolio. This operational leadership role is responsible for Site Management & Monitoring and Clinical Trial Optimization & Strategic Partnership functions.
This role provides strategic leadership for site start-up, site management, and monitoring to drive predictable execution, accelerate timelines, improve enrollment performance, ensure high-quality data, and establish strategic site partnerships.As a member of the Clinical Operations senior leadership team, this role is also responsible for supporting strategic initiatives across the development organization.This is a 4 day onsite position - M-ThKey ResponsibilitiesBuild & lead global site management, monitoring, and study start-up activities across all clinical programsDevelop and execute site strategies to optimize selection, activation, enrollment, and retentionEstablish consistent monitoring models, including risk-based monitoring approachesBuild and maintain strategic relationships with investigative sites, site networks, and partnersPartner closely with Clinical Operations, Clinical Development, Biometrics, and Development Services to ensure seamless, disciplined program and trial executionIdentify and mitigate site-level operational and quality risksEstablish scalable processes, metrics, and dashboards to track and improve site performanceEstablish operating model inclusive of vendor strategy, oversight, risk management, key performance metrics, and dashboardsProvide expert insight into operational strategy plans (feasibility, monitoring strategies) and operating budgetsCreate and continuously improve standard operating procedures, work instructions, to ensure inspection readinessParticipate in regulatory authority inspections, sponsor audits, and oversee site audits in partnership with QualityEnsure compliance with GCP, regulatory requirements, and internal standardsAbility to assess and transform capabilities through AI and Automation solutions or strategiesUp to 20-30% domestic and international travel, as required.QualificationsBachelor's degree in life sciences or related field12+ years of experience in site management or clinical operations leadershipOr advanced degree (PhD, MBA, Masters) and 10+ yrs of experienceDeep expertise in global study start-up and enrollment optimizationStrong people leadership and stakeholder management skills
Executive Director, Head of Global Site Management in princeton at Unknown Company
This position is listed as full time and onsite.