Director, Regional Head – Site Management & Oversight, Europe

Role Overview

• Provides strategic leadership for clinical site operations
• Ensures effective conduct and supervision of site management activities and oversight for clinical programs
• Acts as the strategic link between therapeutic areas and investigator sites
• Leads both permanent and functional service-provider site management teams
• Cultivates strong strategic partnerships with service providers and CROs
• Develops strong and lasting relationships within Medical Affairs at the regional level and with HCPs
• Responsible for operational oversight of the site, site health and monitoring activities
• Supports QA audit and inspection planning, and implementation of CAPAs as needed
• Identifies and proactively mitigates site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs
• Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
• Supports sites in understanding study expectations, timelines, and required deliverables
• Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs
• Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs
• Builds and maintains strong, trusted relationships with investigators and site staff
• Serves as the sponsor primary point of contact for assigned studies
• Understands site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration
• Collects feedback from sites and advocates for process simplification and burden reduction internally
• Identifies opportunities to improve study materials, and operational processes

Requirements

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology
• 12 years+ relevant clinical research experience within the pharmaceutical industry
• Experience in leading and managing a professional team with strong experience in site management, monitoring and overseeing large and/or complex global clinical trials
• A solid understanding of the drug development process, and specifically, each step within the clinical trial process
• Robust budget forecasting and management experience
• Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
• Proven experience in overseeing vendors and CROs
• Must have experience as a mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities
• Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges
• Must have excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development opportunities