About The Position
Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company aims to develop targeted treatments to address cardiovascular diseases. Led by experienced co-founders who previously led MyoKardia, Kardigan possesses a strong discovery and translational research platform, a pipeline of late-stage candidates, and a driven team focused on improving patient lives. Kardigan operates based on core values: patient-driven commitment, authenticity, eagerness to learn, teamwork with urgency and excellence, and enabling the impossible through risk-taking and innovation. The Clinical Trial Liaison (CTL) role is a Director-level position responsible for building relationships with clinical trial investigators and research site staff to facilitate patient recruitment. The CTL acts as the local field-based representative for Kardigan, supporting clinical study execution in a specific region. This role involves significant interaction with investigator sites and other parties involved in clinical trial execution, with potential for up to 70% travel. The CTL provides regional insights for study feasibility, site selection, and patient recruitment/retention, and collaborates with study teams to resolve site issues. A key aspect of the role is ensuring investigators and site staff have a thorough scientific understanding of investigational agents, eligibility criteria, and study procedures. The CTL also assesses the effectiveness of site strategies for identifying eligible subjects and understands how trials fit into the site's treatment patterns and potential impacts from competing trials or drug approvals. Regular interaction is required to maintain trial focus with investigators and staff. The CTL functions as part of the study and CRO teams, serving as a liaison to ensure investigators receive assistance and their concerns are communicated to the sponsor.
Requirements
- Minimum Bachelor’s degree, master’s preferred or terminal degree (MD, PhD or PharmD)
- 10+ years relevant industry and/or CRO experience required
- Extensive experience in site facing clinical trial operations required
- Extensive medical and scientific knowledge and clinical development understanding
- Excellent communicator of technical and scientific information
- Excellent interpersonal skills and demonstrated collaborative as well as independent working style
- Ability to build relations with the external medical community
- Proactive and self-motivated, ability to align activities with the clinical development plans (CDPs)
- Strong organizational skills with effective use of time and prioritization
- Cross cultural awareness
- Fluency in English and in local language in country of residence required
- A working knowledge of ICH/GCP
- Computer skills including Excel, Word, and PowerPoint
- A willingness to travel frequently within assigned geographical territory, including overnight travel.
- Valid driver’s license
Nice To Haves
- Cardiovascular clinical trial experience and expertise in cardiovascular disease (e.g., heart failure, cardiomyopathies, hypertension, cardiometabolic disease, etc.) preferred
Responsibilities
- Provide country/regional operational insight into site feasibility and selection and overall patient recruitment strategy
- Identify and cultivate high-quality cardiovascular investigators
- Communicate scientific and clinical information clearly and accurately, ensuring sites understand study objectives, rationale, investigational product profile, and any updates or amendments.
- Collaborate with Clinical Operations and Clinical Development
- Participate in clinical study team meetings and quality meetings where necessary providing input to study teams on operational issues based on site visits and contacts
- Attend and present at SIVs, investigator meetings, monitor workshops/training
- Participate in site visits with investigator site staff and/or CRO representatives, or independently, in support of clinical trial execution and report back to study teams e.g. feasibility, startup activities, enrolment or escalated study/site issues
- Support enrollment and retention efforts through tailored discussion, data-driven insights, and strong relationship-building
- Responsible for review, documentation and follow up of investigator site issues including tracking metrics
- Provides sponsor regional operational support and acts as point of escalation for investigator sites as appropriate
- Identify and escalate site needs, barriers, or operational challenges to the Clinical Operations and Medical teams.
- Participate in Regulatory GCP inspections and/or audits at investigator sites as sponsor representative
- Complete all administrative responsibilities consistent with SOPs and departmental guidelines including but not limited to required training, field activity documentation, expense reporting, and other assigned tasks
- Understand the scientific basis of assigned clinical trials
- Support creation of educational materials to effectively communicate the science behind the clinical trial
- Be able to communicate the scientific basis of the trials to other team members, investigators and site staff
- Identify effective prescreening strategies for each trial and recommend improvements
- Provide detailed reports of interactions with investigators and site staff
- Partner with Medical Affairs, Clinical Operations, and other cross-functional stakeholders to ensure consistent messaging and aligned site support.
- Ensure all interactions comply with regulatory, ethical, and company standards.
Benefits
- Exact Compensation may vary based on skills, experience and location.
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What This Job Offers
Job Type
Full-time
Career Level
Director
