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At Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029.
The Opportunity
Ready to transform clinical trial delivery? We are looking for a Country Clinical Operations Excellence Lead to drive portfolio-wide improvements and boost productivity. In this role, you will be pivotal in shaping and leading initiatives that implement new operational models with internal and external partners, directly impacting clinical trial outcomes. You'll work at the forefront of innovation, tackling critical needs and collaborating with key stakeholders across the enterprise to ensure strategic alignment and drive efficiency.
Lead strategic initiatives: Develop and implement plans for Clinical Operations Excellence (CoE) initiatives that support our business objectives.
Innovate trial execution: Stay ahead of external trends and best practices, enhancing our learning and knowledge management programs to maintain a competitive edge.
Drive process improvements: Lead teams in creating and implementing enhanced global and local processes, policies, and training programs to boost efficiency, standardization, and a strong compliance culture.
Ensure quality and compliance: Maintain compliance with all relevant regulations (GCP/GVP), oversee audits, safeguard data integrity, and act as a key liaison with regulatory authorities.
Mentor and coach teams: Provide leadership and guidance to cross-functional teams, solving complex challenges and contributing to the operational strategy for clinical trial execution.
Who You Are
You are a senior-level professional with deep expertise in clinical trial operations and a passion for driving change. You are a self-starter who can autonomously prioritize tasks and guide teams in formulating strategic plans. You thrive on solving complex problems, and you have a proven track record of interpreting business challenges and regulatory issues to implement best practices. You are a leader who inspires and develops talent, committed to building an inclusive, high-performing culture.
You have the following qualifications:
A minimum of 8 years of relevant experience in clinical trial operations in areas such as process, compliance, vendor management, and systems.
Specialized depth and/or breadth of expertise in Drug Development and proficient knowledge of Clinical Operations.
The ability to interpret internal/external business challenges and regulatory issues and recommend best practices to improve clinical trial conduct.
Proven ability to lead, mentor, and coach cross-functional teams.
Experience in leading projects that drive clinical trial infrastructure initiatives.
A proven track record of solving complex outcomes using sophisticated analytical thought to identify innovative solutions.
Expertise in the Ukrainian Regulatory Landscape: Ability to interpret and apply relevant Ukrainian legislation and proactively influence local regulations by engaging with the regulatory body and key industry associations.
Operational Insight: A deep, practical understanding of the Ukrainian operating environment, enabling the design and establishment of robust operational processes.
Language Proficiency: Native fluency in Ukrainian and professional working proficiency in English.
#ClinOps
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.