Senior Director, Head of Clinical Compliance & Speciality Operations
Senior Director, Head of Clinical Compliance & Speciality Operations
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1 Vacancy
Job Description
CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
TheHead of Clinical Compliance and Specialty Operationsis a senior leadership role responsible for ensuring that clinical development activities are conducted in full compliance with global regulatory requirements internal policies and Good Clinical Practice (GCP) standards. This role also provides strategic and operational oversight for specialized clinical operations functions including clinical lab sample management TMF operations and the execution of studies via full-service outsourcing (FSO) models.
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
Extensive understanding of the clinical research and drug development lifecycle
10 years of professional work experience in a Clinical Development/Research environment
Thorough knowledge of ICH GCP FDA GCP Regulations and EU clinical trials directives
Ability to lead and influence programs of change across many groups not in the direct line of supervision
Proven leadership and global Clinical Operations experience is essential
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 operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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!
Required Experience:
Exec
Employment Type
Full-Time
