Associate Director Clinical Process Excellence

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Support the design, implementation, and continuous optimization of clinical process frameworks and quality systems for clinical development, ensuring efficient management of SOPs, templates, regulatory intelligence, training, audits, and operational processes; drive standardization, compliance, and cross-functional collaboration to enable high-quality clinical execution and operational excellence.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Process Governance & Standardization: Support implementation and maintenance of clinical process governance frameworks, including SOP systems, templates, and process forums to ensure consistency and efficiency. 
• Quality System Management: Contribute to the development, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring alignment with regulatory and organizational standards.
• Documentation & Knowledge Management: Ensure effective management of clinical documentation including SOP repositories, eTMF templates, and knowledge systems to support compliance and accessibility.
• Regulatory Intelligence & Compliance Oversight: Monitor regulatory developments and support translation into process updates to maintain compliance with evolving requirements.
• Training & Capability Building: Support clinical training strategy and delivery, including GCP and process training, ensuring compliance and capability development.
• Audit, Inspection & Continuous Improvement: Support audits, inspections, and CAPA activities; ensure timely remediation and promote continuous improvement and inspection readiness.
• Cross-functional Collaboration & Operational Support: Partner with cross-functional stakeholders to support integrated process execution and operational initiatives.

 

Minimum Requirements: 
  Work Experience:

• 10+ years pharmaceutical industry clinical experience in Development and Clinical Operations.

 Skills:

• Excellent leadership, communication (written/verbal), stakeholders’ management and collaboration skills
• Excellent organizational skills, with the ability to prioritize/work effectively in a changing environment
• Extensive experience in conducting a wide range of study types and the end-to-end clinical process
• Experience in people management (optional)
• Strong interpersonal, problem-solving, change management and negotiation skills
• Displays strategic thinking, an innovative mindset and a solutions-oriented approach
• Experience in a global environment with the ability to lead cross functional, multi-cultural teams
• Ability to work independently and create innovative solutions with little direction

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! 

Join us!

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Project Management