Director, Clinical Trial Liaison - Northern Midwest: Illinois; Indiana; Mic at Kardigan

, , United States -

Full Time

Start Date

Immediate

Expiry Date

02 Aug, 26

Salary

318000.0

Posted On

04 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical trial operations, Cardiovascular disease expertise, Site management, Patient recruitment, Relationship building, Scientific communication, Clinical development, Feasibility assessment, Regulatory compliance, GCP, ICH, Data analysis, Project management, Strategic planning, Cross-functional collaboration

Industry

Biotechnology Research

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. Job Title: CLINICAL TRIAL LIAISON (CTL) Level: Director Region: Northern Midwest : Covering Illinois; Indiana; Michigan; Minnesota; Missouri; Iowa; North Dakota 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 Exact Compensation may vary based on skills, experience and location. Pay range $244,000—$318,000 USD

Responsibilities

The Clinical Trial Liaison will build and maintain relationships with clinical investigators to facilitate patient recruitment and ensure successful trial execution. They will provide regional operational insights, troubleshoot site issues, and ensure site staff have a thorough scientific understanding of the investigational agents.