Senior Director, Head of Clinical Compliance & Speciality Operations
New Today
Clinical Compliance Leadership Lead the development, implementation, and continuous improvement of the clinical compliance framework across all therapeutic areas.
Serve as the primary point of contact for inspection readiness and regulatory audits.
Partner with Quality Assurance and Clinical Operations to identify, assess, and mitigate compliance risks.
Ensure harmonization of compliance practices across global teams and integration of acquired entities or business units.
Oversight of Specialty Operations Trial Master File (TMF):Oversee the TMF team to ensure timely, accurate, and inspection-ready documentation in alignment with ICH-GCP and internal SOPs.
Clinical Lab Sample Management:Provide strategic direction and operational oversight for the Center of Excellence (CoE) in lab sample management, ensuring robust interfaces with research and clinical teams.
Full-Service Outsourcing (FSO):Provide strategic direction and ensure operational infrastructure is developed and implemented for FSO delivery models.
Strategic Operations & Governance Collaborate with the Head of Clinical Operations and other functional leaders to shape the future-state operating model, including phased implementation plans (e.g., Day 1, Month 3, etc.).
Support the development of operational KPIs and dashboards to monitor compliance and operations performance.
Qualifications & Experience Requirements Degree (BSc/MSc/Diploma) in scientific/medical/pharmaceutical discipline is essential, preferably combined with relevant clinical trial
experience
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Extensive understanding of the clinical research and drug development lifecycle
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10+ years of professional work experience in a Clinical Development/Research environment
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Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives
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Ability to lead and influence programs of change across many groups not in the direct line of supervision
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Proven leadership and global Clinical Operations experience is essential
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Proven track record in leading global teams
Our Benefits
We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL. 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 worlds 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. We want CSL to reflect the world around us
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. Learn more Inclusion and Belonging | CSL Do work that matters at CSL Behring! TPBN1_UKTJ
- Location:
- Gb
- Job Type:
- FullTime
- Category:
- Health;Finance;Health;Management;Finance