Country Clinical Operations Excellence (CoE) Lead

 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.

As a Country Clinical Operations Excellence (CoE) Lead in PDG, you will be pivotal in driving portfolio-wide improvements and boosting clinical trial delivery productivity. This position involves fostering innovative trial execution, tackling critical needs, and collaborating with key stakeholders across PDQ, pRED, gRED, USM, and PDMA. You will lead and shape initiatives to implement new operational models with both internal and external partners, ultimately impacting clinical trial delivery.

The Opportunity

• Develop the strategy and  implementation plan of CoE initiatives that support PDG's business objectives.

• Oversee the execution and governance of initiatives within global PDG Clinical Operations and with external stakeholders.

• Collaborate with various stakeholders across the enterprise internally and externally such as Study Teams, PDQ, Countries, pRED, gRED etc., to ensure strategic alignment and drive innovation.

• Stay ahead of external learning trends, technologies, and best practices to enhance learning and knowledge management programs and maintain PDG's competitive edge.

• Impact Measurement: Communicate the outcomes of CoE initiatives, such as improved operational efficiency, enhanced decision-making, increased employee engagement, and accelerated innovation.

• Provide coaching, support and leadership, as part of the Roche Leadership Framework, to a group of approx. 5-8 direct reports. By exemplifying our Roche values, Leadership commitments and modeling our Roche Operating Principles, you will ensure we achieve our ambitions for our people and patients.

• Conduct a regular year-round assessment of performance, contributions, and impact and provide feedback, coaching, and performance management. Lead by example in demonstrating and championing inclusive behaviors in your team, PDG, PD, and the Roche Enterprise. Provide opportunities for growth and development for all team members and address any barriers that may exist. 

• People management-related administration (e.g. Workday People & Culture Management system tasks) and contact for employment-related matters.

• Leads teams in the creation, improvement and implementation of enhanced global and local processes, policies, and training programs to drive efficiency, standardization, and a strong compliance culture both internally and with our CRO partners/vendors. Ensures maintenance of global and local regulatory compliance (GCP/GVP/IxD/GMP), oversees audit support and corrective action management, safeguards data quality and integrity, leads the development and monitoring of interventional trial compliance (AMCO/global), and acts as a key liaison with regulatory authorities.

• May be a Global Process Owner and or Business Process Owner

• Drives the implementation and management of defined clinical operations business processes, ensuring adherence to standards and procedures. Monitors process performance, identifies areas for improvement, and collaborates with stakeholders including CRO partners to implement necessary changes.

• Architect and lead a forward-thinking learning management strategy for Clinical Operations, encompassing both internal and CRO partner training oversight, focused on building future capabilities through innovative learning solutions.

• Drives efficiency and empowers decision-making by ensuring timely access to critical information, thereby ensuring the organization remains at the leading edge of clinical trial execution.

• Architects and drives a strategic Knowledge Management framework, deliberately integrating advancements in AI to fuel innovation, operational efficiency, and ensure real-time access to critical information for data-driven decision-making, maintaining Clinical Operations as a leader in these fields.

• Orchestrates the timely adoption and full embedding of cutting-edge AI technologies and knowledge management tools, strategically leveraging data to optimize operational efficiency, enhance outcomes, and establish Clinical Operations as an influential innovator in knowledge management and AI application.

• Leads the development and implementation of program-wide IxRS and eCOA strategies and standards in collaboration with program leadership.