Kardigan
Executive Director, Head of Global Site Management
Princeton, New Jersey · Director
Sponsorship not specified$20k-$30kDetected 33 days ago
GCPResearchLeadership
About the role
- 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.
- These values are the foundation of our work, empowering us to make a real difference, every day.
Responsibilities
- Build & lead global site management, monitoring, and study start-up activities across all clinical programs
- Develop and execute site strategies to optimize selection, activation, enrollment, and retention
- Build and maintain strategic relationships with investigative sites, site networks, and partners
- Partner closely with Clinical Operations, Clinical Development, Biometrics, and Development Services to ensure seamless, disciplined program and trial execution
- Create and continuously improve standard operating procedures, work instructions, to ensure inspection readiness
Requirements
- Bachelor's degree in life sciences or related field
- 12+ years of experience in site management or clinical operations leadership
- Or advanced degree (PhD, MBA, Masters) and 10+ yrs of experience
- Deep expertise in global study start-up and enrollment optimization
- Up to 20-30% domestic and international travel, as required.
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Compensation
- $20k-$30k
Company info
- 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 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.
- Establish consistent monitoring models, including risk-based monitoring approaches
- Identify and mitigate site-level operational and quality risks
- Establish scalable processes, metrics, and dashboards to track and improve site performance
- Establish operating model inclusive of vendor strategy, oversight, risk management, key performance metrics, and dashboards
- Provide expert insight into operational strategy plans (feasibility, monitoring strategies) and operating budgets
- 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 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.
- Role Summary
- 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-Th
- Participate in regulatory authority inspections, sponsor audits, and oversee site audits in partnership with Quality
- Ensure compliance with GCP, regulatory requirements, and internal standards
Visa & Work Authorization
- Participate in regulatory authority inspections, sponsor audits, and oversee site audits in partnership with Quality
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This listing is sourced directly from Kardigan's careers page and normalized into a canonical job model.