Director, Clinical Trial Liaison - Mid Atlantic Region (NJ, NY, PA, MA, MD)

Job Title: CLINICAL TRIAL LIAISON (CTL)

Level: Director

Region: Mid Atlantic: Covering New Jersey; New York; Pennsylvania; Massachusetts; Maryland

Reports to: Senior Director or above, Clinical Operations

The Clinical Trial Liaison (CTL) will develop relationships with clinical trial investigators and research site staff to facilitate recruitment of subjects in Kardigan clinical trials.  The Clinical Trial Liaison (CTL) supports Global Development clinical study execution as the local field-based representative for Kardigan in one or more countries/regions supporting clinical development programs. The CTL interacts with investigator sites and other parties related to clinical trial execution.  Depending on trial needs and status, some periods will involve extensive travel, up to 70%, to support site teams, troubleshoot challenges, and foster strong, collaborative relationships.

The CTL provides regional and country specific insights to support study feasibility, site identification and selection, and patient recruitment and retention initiatives. In collaboration with the study team, the CTL both identifies and helps facilitate resolution of investigator site issues.

The CTL will work in concert Kardigan’s clinical trial teams to ensure that investigators and site staff have a thorough scientific understanding of the investigational agents being used in the study, the trial’s eligibility criteria, and all study procedures. Particular attention will be given to assessing the effectiveness of each site’s strategy used to identify potentially eligible subjects. The CTL must also understand how the trial fits into the site’s pattern of treatment for the condition and how any competing clinical trials or upcoming drug approvals may affect the progress of recruitment. Repeated interactions will be needed over the course of the trial to ensure that the trial remains “top of mind” with investigators and staff. The CTL will function as part of the study and CRO teams. Furthermore, the CTL will serve as liaison with key investigators to help ensure that they receive assistance with any queries and that any concerns they have are promptly transmitted to the trial’s sponsor.

Duties and 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.

Qualifications and Experience:

• 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 (e.g., heart failure, cardiomyopathies, hypertension, cardiometabolic disease, etc.) 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, 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