Clinical Operations Excellence; CoE Lead

Position: Country Clinical Operations Excellence (CoE) Lead
The Position

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 for the US. 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

• Drive the development and implementation of CoE/ operational excellence strategies (with internal/ external stakeholders) that enables PDG's US business objectives in alignment with the US Leadership Team and Global CoE.
• Architect and lead a forward-thinking learning management strategy for US Clinical Operations delivery, encompassing both internal and CRO partner training & oversight, focused on building future capabilities through innovative learning solutions.
• 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.
• Responsible for local and regional clinical operations excellence, encompassing vendor oversight, compliance strategies/oversight for interventional trials, and change management, all while ensuring alignment with global CoE and regulatory standards. Act as a primary liaison between various stakeholders, including CRO partners, regulatory authorities, and internal teams (ex medical compliance), and contributes to strategic planning and continuous improvement initiatives, including potentially country leadership and people management.
• Lead 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.
• Provide coaching, support and leadership, as part of the Roche Leadership Framework, to a group of approx. 5-8 direct reports. This includes conducting 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.
• Ensure 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.
• Conduct a regular year-round assessment of performance, contributions, and impact and provide feedback, coaching, and performance management.
• 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.
• 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.
• May be a Global Process Owner and or Business Process Owner
• Drives the implementation and management of defined clinical…