Clinical Trial Liaison Associate Director

Job Description

General Summary:

Vertex has established the Clinical Trial Liaison (CTL) role that transforms the Clinical Research site experience with Vertex by making the customer experience a priority. This is a strategic role that acts as a critical interface between Vertex and Clinical Research sites primarily for therapeutic area networking and site outreach, education, specialized trainings, and enrollment accelerations. Reporting to the Director, GCO, Patient and Site Engagement, the CTL/Associate Director must have an in-depth understanding of clinical research and associated regulatory requirements in the region and provide team leadership and/or specific operational & expertise in multiple therapeutic areas.

Key Duties and Responsibilities:

• Serve as a professional, competent and reputable Vertex representative in direct interaction with clinical trial investigators, academic institutions, and therapeutic area networks related to studies in feasibility and site selection, and conduct routine visits during the life of a study
• Identify new sites for consideration, conducting therapeutic area network and site outreach and influence Vertex culture about clinical research. Include focus on diverse investigators in underrepresented communities.
• Identify opportunities for process improvements to achieve better results in study execution and feedback information to the functions and study teams
• Key decision maker in country/site selection activities, representing regional insight and interests in collaboration with Medical Affairs, including new sites and new regions
• Participation in Clinical Trial Allocation Committee meetings
• Understand the scientific aspects of a protocol that will help with site engagement, indication investigation, determining the key eligibility criteria for trail subjects ensuring trial success at participating sites
• Support site training through discussions of the investigational product and provide the rational for study design and key eligibility criteria in collaboration with Clinical Development
• Conduct specialized trainings
• Can provide additional support to prioritized programs as needed
• Define, monitor and report Key Performance Indicators (KPIs) for site performance
• Stay abreast of regulations and industry trends and proactively prepare to maintain compliance
• Leverage in-depth understanding of local regulations and trial implementation pathways to ensure streamlined site start-up
• Take on a Disease Area Lead role to streamline communication between project teams and CTLs
• Provide input into the development of feasibility questionnaires
• Develop and manage relationships with external site and therapeutic area networks
• Travel may be required up to 50% of time

Knowledge and Skills:

• Proven track record of managing long-term professional relationships (e.g. Clinical sites)
• Must have good working knowledge of ICH, FDA, EU-CTR, IRB/IEC and other applicable regulations/guidelines and significant experience with Clinical Site start-up documents
• Experience in Vertex Therapeutic Areas a plus
• Fluency in English
• Fluency in other languages is a plus

Education and Experience:

• Bachelor’s degree
• Requires 8 years of experience in Clinical Development or the equivalent combination of education and experience

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as: 
1.    Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 
2.    Hybrid: work remotely up to two days per week; or select
3.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Remote

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]