Key Duties and Responsibilities
- Act as Vertex representative with clinical trial investigators, academic institutions, and therapeutic area networks; conduct routine study visits.
- Identify and outreach to new sites; support feasibility and site selection; include focus on diverse investigators in underrepresented communities.
- Identify process improvement opportunities to enhance study execution and share feedback with functions/study teams.
- Serve as key decision maker for country/site selection in collaboration with Medical Affairs.
- Participate in Clinical Trial Allocation Committee meetings.
- Understand protocol science to support site engagement, indication investigation, and key eligibility criteria.
- Support site training (investigational product, study design rationale, eligibility criteria) with Clinical Development; conduct specialized trainings.
- Provide additional support for prioritized programs as needed.
- Define, monitor, and report KPIs for site performance.
- Maintain regulatory compliance by staying current on regulations/industry trends; leverage local regulations to streamline site start-up.
- Lead disease-area communications between project teams and CTLs; provide input into feasibility questionnaires.
- Develop and manage relationships with external sites and therapeutic area networks.
- Travel up to 50%.
Qualifications / Education
- Bachelorβs degree.
- 8 years of experience in Clinical Development (or equivalent combination of education/experience).
- Working knowledge of ICH, FDA, EU-CTR, IRB/IEC and related guidelines; significant experience with clinical site start-up documents.
Skills / Requirements
- Proven track record managing long-term professional relationships (e.g., clinical sites).
- Fluency in English; other languages a plus.
- Experience in Vertex therapeutic areas is a plus.
Work Arrangement
- Remote-eligible (Remote, Hybrid, or On-Site options subject to Flex program policy).