Clinical Trial Liaison Associate Director

Vertex Inc. • Boston, MA

1d • Remote

About The Position

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.

Requirements

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

Nice To Haves

• Experience in Vertex Therapeutic Areas a plus
• Fluency in other languages is a plus

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

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees