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.
Role Summary
The Head of Clinical Operations is a senior leadership role responsible for the end-to-end execution of global clinical trials, ensuring delivery on timelines, quality, and budget. This role leads the Clinical Trial Management and Global Site Management functions, providing strategic and operational oversight across all phases of development. This role is a member of the Development Operations & Biometrics leadership team, and, as such, contributes to portfolio strategy, evidence generation, and long-range planning.
The position is accountable for translating development strategy into executable clinical plans, building scalable operating models, and ensuring compliant, high-quality trial conduct across regions and sites.
Key Responsibilities
- Provide strategic and operational leadership for the planning and execution of global clinical trials across the portfolio.
- Oversee study start-up, conduct, and close-out activities in collaboration with cross-functional partners.
- Ensure clinical trials are delivered on time, within scope, and within budget.
- Establish standardized trial management processes, tools, and metrics to support consistency and scalability.
- Serve as the primary operational escalation point for study-level risks, issues, and mitigation strategies.
- Build and oversee the Global Site Management function, ensuring global site strategy, including site identification, feasibility, selection, initiation, monitoring, and close-out.
- Oversee regional and global monitoring models (in-house, hybrid, CRO-managed, RBQM).
- Develop and guide site engagement, performance, and retention strategies to optimize enrollment, quality, and timelines.
- Ensure consistent application of GCP, ICH, and regional regulatory requirements across sites.
- Partner with Quality Assurance to support inspections, audits, and CAPA management related to site activities.
- Drive enrollment acceleration initiatives and proactive risk-based approaches to recruitment and retention.
- Monitor enrollment performance and implement corrective actions as needed.
- Partner with Development Services, Procurement, and Legal to support CRO and vendor oversight.
- Provide clinical operations input into vendor selection, governance, and performance management.
- Collaborate closely with Biometrics, Regulatory, Medical, Quality, and Safety to ensure integrated trial execution.
- Build, lead, and develop high-performing Clinical Trial Management and Site Management teams.
- Establish clear roles, responsibilities, and career pathways within Clinical Operations.
- Support organizational growth by designing scalable operating models and resourcing strategies.
- Ability to assess and transform capabilities through AI and Automation solutions or strategies
- Foster a culture of accountability, quality, and continuous improvement.
- Up to 20-30% domestic and international travel, as required.
Qualifications & Preferred Skills
- Bachelor’s degree in Life Sciences required; advanced degree (MS, MPH, PharmD, PhD) preferred.
- 15+ years of clinical operations experience within biotech, pharma, or CRO environments. 12+ years with an advanced degree
- Proven leadership experience overseeing clinical trial management and global site management functions.
- Experience leading global, multicenter trials across multiple phases, including late-stage and registration studies preferred.
- Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.