Director, Regional Head Site Mgmt

Description and SummaryThe Director, Regional Head Site Management & Oversight provides strategic leadership for clinical site operations, ensuring the effective conduct and supervision of site management activities and oversight for clinical programs within the assigned region. This includes alignment with our overall strategy, adherence to international regulatory standards, and delivery within agreed timelines and budget. Acting as the strategic link between therapeutic areas and investigator sites, the role ensures high-quality execution of clinical programs. The Regional Head will lead both permanent and functional service-provider site management teams while cultivating strong strategic partnerships with service providers and CROs. The Regional Head will also develop strong and lasting relationships within Medical Affairs at the regional level and with HCPs. Main Responsibilities Clinical Oversight & Compliance Responsible for operational oversight of the site, site health and monitoring activitiesSupport QA audit and inspection planning, and implementation of CAPAs as neededIdentify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs Study Delivery Support Provide study support on escalated site issues related to study delivery by coordinating communications and resolution effortsSupport sites in understanding study expectations, timelines, and required deliverablesBe accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROsResponsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs Site Relationship & Engagement Build and maintain strong, trusted relationships with investigators and site staff – Face of CSLServe as the sponsor primary point of contacted for assigned studiesUnderstand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaborationThis role will require travel to Investigator Meetings, Investigator sites and CROs. Anticipated travel >50% Continuous Improvement & Site Experience Collect feedback from sites and advocate for process simplification and burden reduction internallyIdentify opportunities to improve study materials, and operational processesRepresent the “voice of the site” in cross-functional discussions and initiatives Feasibility & Site Selection Provide local site intelligence to feasibility teamsSupport site development Qualifications and Experience 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 About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at . Our Benefits