Position Description and Summary
The 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 activities
Support QA audit and inspection planning, and implementation of CAPAs as needed
Identify 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 efforts
Support 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
Site Relationship & Engagement:
Build and maintain strong, trusted relationships with investigators and site staff – Face of CSL
Serve as the sponsor primary point of contacted for assigned studies
Understand site capabilities, constraints, and strategic priorities to improve site engagement and long‐term collaboration
This 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 internally
Identify opportunities to improve study materials, and operational processes
Represent the "voice of the site" in cross‐functional discussions and initiatives
Feasibility & Site Selection:
Provide local site intelligence to feasibility teams
Support 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well‐being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
#J-18808-Ljbffr