Director, Clinical Trial Liaison

Stellenbeschreibung:

Develop relationships with clinical trial investigators and research site staff to facilitate recruitment of subjects in Kardigan clinical trials
Support Global Development clinical study execution as the local field-based representative
Interact with investigator sites and other parties related to clinical trial execution
Travel up to 70% as needed to support site teams, troubleshoot challenges, and foster collaborative relationships
Provide regional and country-specific insights for study feasibility, site identification and selection, and patient recruitment and retention
Identify and help resolve investigator site issues with the study team
Ensure investigators and site staff understand investigational agents, eligibility criteria, and study procedures
Assess site strategies for identifying eligible subjects and understand competing trials or upcoming approvals affecting recruitment
Liaise with key investigators and transmit site queries or concerns to the sponsor
Provide regional operational insight into site feasibility, selection, and patient recruitment strategy
Identify and cultivate high-quality cardiovascular investigators
Communicate scientific and clinical information, including study objectives, rationale, investigational product profiles, and updates
Collaborate with Clinical Operations, Clinical Development, Medical Affairs, Clinical Operations, and other cross-functional stakeholders
Participate in study team and quality meetings, SIVs, investigator meetings, monitor workshops, and training
Conduct or participate in site visits and report feasibility, startup, enrollment, and escalated site issues
Support enrollment and retention through tailored discussions, data-driven insights, and relationship-building
Review, document, follow up, and track investigator site issues and metrics
Serve as sponsor regional operational support and escalation point for investigator sites
Participate in Regulatory GCP inspections and/or audits as sponsor representative
Complete SOP-compliant training, field activity documentation, expense reporting, and assigned administrative tasks
Support educational materials and communicate trial science to team members, investigators, and site staff
Identify prescreening strategies and recommend improvements
Provide detailed reports of investigator and site staff interactions
Ensure interactions comply with regulatory, ethical, and company standards

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
Cardiovascular clinical trial experience and expertise in cardiovascular disease preferred
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, with ability to align activities with clinical development plans (CDPs)
Strong organizational skills with effective use of time and prioritization
Cross-cultural awareness
Fluency in English and in the local language in country of residence required
Working knowledge of ICH/GCP
Computer skills including Excel, Word, and PowerPoint
Willingness to travel frequently within assigned geographical territory, including overnight travel
Valid driver's license

Core Competencies

Demonstrates extensive experience in clinical trial operations, particularly in cardiovascular studies, with a strong ability to build relationships with investigators and site staff. Proficient in communicating complex scientific information and ensuring compliance with regulatory standards.