Senior Director, Head of Clinical Compliance & Speciality Operations

CSL Behring UK; Maidenhead; On-site; GBP 80,000 - 110,000; Full time

Job summary

A global biotherapeutics leader in Maidenhead is looking for a Head of Clinical Compliance and Specialty Operations. This senior role ensures compliance with global regulatory requirements while providing strategic oversight for clinical operations. Candidates should have a degree in a scientific field and at least 10 years of experience in clinical development, with a proven track record of leading global teams. The position emphasizes risk management and operational excellence, fostering an agile, innovative approach to improve patient outcomes.

Benefits

Comprehensive health benefits

Wellness programs

Career development opportunities

Qualifications

• 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.

Responsibilities

• Lead the development, implementation, and continuous improvement of the clinical compliance framework.
• Oversee the TMF team to ensure timely, accurate, and inspection-ready documentation.
• Provide strategic direction and operational oversight for lab sample management.
• Collaborate with functional leaders to shape future-state operating models.

Skills

Risk Management

Negotiation

Operational management

Smartsheets

Strategic Planning

Team Management

Budgeting

Leadership Experience

Program Development

Supervising Experience

Financial Planning

Education

Degree (BSc / MSc / Diploma) in scientific / medical / pharmaceutical discipline

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.

The Head of Clinical Compliance and Specialty Operations is 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 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 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!

Key Skills

Risk Management,Negiotiation,Operational management,Smartsheets,Strategic Planning,Team Management,Budgeting,Leadership Experience,Program Development,Supervising Experience,Financial Planning

Employment Type: Full-Time

Vacancy: 1