Sr. Director, Clinical Trial Optimization

Job description

**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 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. **Position Title:** Senior Director, Clinical Trial Optimization **Department:** Clinical Operations, Global Site Management **Reports To:** Executive Director, Global Site Management **Location:** Princeton, NJ, United States (4 days per week onsite M-Th) **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. 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. **Job Overview** Kardigan is seeking an experienced Senior Director, Clinical Trial Optimization to establish and lead a new internal capability spanning feasibility and enrollment planning and forecasting, protocol optimization, study start-up, and patient engagement and experience. Sitting within the Global Site Management pillar of Clinical Operations, this leader will define the operating model, build the team, and ensure enrollment, country, and site assumptions are evidence-based, risk-adjusted, and operationally sound before a study advances through governance. This is the first role of its kind at Kardigan. The successful candidate will set functional strategy while personally delivering early portfolio work, scaling the team in phases as the pipeline grows. Partnering with Digital Health Innovation & AI Enablement, Clinical Trial Management, Clinical Development, Medical Affairs, Development Services, and other enterprise stakeholders, this leader will also serve as a Clinical Operations business owner for the trial design, feasibility, and site activation solutions on Kardigan’s AI and digital transformation roadmap. **Essential Duties and Responsibilities** - Define the vision, operating model, and phased roadmap for Clinical Trial Optimization, including which capabilities are built internally and how sponsor oversight of outsourced activities is applied. - Build the capability across feasibility and enrollment planning and forecasting, protocol optimization, study start-up, and patient engagement and experience, sequencing the build to portfolio needs. - Recruit, develop, and lead the team, operating hands-on while the function scales, and establish the processes, tools, data sources, and vendor strategy required to support it. - Own feasibility and enrollment planning for the portfolio, ensuring enrollment, country, and site assumptions are evidence-based, risk-adjusted, and endorsed before studies advance through governance. - Bring an operational lens to protocol design in partnership with Clinical Trial Management, Clinical Development and other cross enterprise functions, reducing complexity, patient and site burden, and avoidable amendments. - Set the strategy for study start-up and site activation, partnering with Clinical Trial Management and Development Services to improve predictability and cycle time. - Establish the approach to patient engagement and experience, integrating it into study design and feasibility, and oversee the vendors, digital channels, and advocacy partnerships that support it. - Serve as the Clinical Operations business owner for the trial design, feasibility, and site activation solutions on Kardigan’s AI and digital transformation roadmap, partnering with Digital Health Innovation & AI Enablement on design, validation, and adoption. - Define the performance measures for the function and use projected versus actual performance to continuously improve assumptions, models, and standards. - Represent Clinical Trial Optimization with Clinical Operations, Development, and enterprise stakeholders in governance and stage-gate forums, and monitor industry and regulatory developments to inform strategy. - Requires approximately up to 20% domestic and international travel. **Qualifications and Preferred Skills** - Bachelor’s degree in life sciences or a quantitative discipline; advanced degree (MS, MPH, MBA, PharmD, or PhD) preferred. - 12+ years in pharmaceutical, biotechnology, or CRO global clinical development, including significant leadership in feasibility, trial optimization, study start-up, and/or patient recruitment. - Demonstrated experience building a capability or team from the ground up and creating structure where none exists. - Proven ability to challenge and validate CRO enrollment, start-up, and site assumptions in an outsourced or hybrid delivery model. - Hands-on experience building enrollment forecasting models, feasibility tools, and operational benchmarks; fluency with industry data sources (e.g., Citeline, TriNetx, RWE data) and CTMS systems. - Working understanding of predictive modeling, automation, and AI applications sufficient to define use cases and evaluate limitations. - Strong knowledge of ICH-GCP, global regulatory requirements, and the country start-up landscape; cardiovascular or other competitively enrolling therapeutic area experience preferred. - Exceptional communication and executive presence, translating complex analyses into decision-ready recommendations for senior leadership, and people leadership experience including hiring, performance management, and career development. **Leadership Competencies** - **Enterprise Leadership:** Puts enterprise interests above those of the individual or function; builds and inspires high-performing teams. - **Influence and Informed Challenge:** Shapes decisions across functions without direct authority and challenges assumptions with evidence. - **Results-Driven with Urgency:** Assumes personal accountability for outcomes, reduces cycle time, and acts decisively. - **Enables the Impossible:** Takes considered risks to unlock innovation and champions change in a rapidly scaling organization. Exact Compensation may vary based on skills, experience and location. Pay range $242,000—$315,000 USD