Country Clinical Operations Excellence (CoE) Lead

Genentech • Daly City, CA

6d

About 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 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.
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.
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.

Requirements

• You hold a Bachelor’s or Master’s degree in a scientific, medical, or healthcare-related field and bring a strategic, enterprise mindset to clinical operations leadership.
• You bring deep and broad drug development and clinical operations expertise, viewed as a trusted technical and operational leader within Clinical Operations or a related discipline.
• You are recognized as a senior expert with 10+ years of experience across clinical operations domains such as process & clinical operations excellence, compliance, vendor & partner management, systems, and learning—applying critical thinking to solve complex, ambiguous problems at scale.
• You are an experienced people leader with a proven track record of building, developing, and inspiring high-performing teams, including proactively coaching, mentoring, and growing direct reports to meet both individual and organizational goals.
• You operate with a high degree of autonomy, setting priorities with limited oversight while shaping and translating strategy into executable plans that drive measurable improvements in clinical trial infrastructure and delivery.
• You are adept at anticipating business, organizational, vendor, and regulatory challenges, and you lead the design and implementation of sustainable solutions—bridging gaps across functions, geographies, and partners to improve outcomes.
• You architect and lead complex, cross-functional initiatives, uniting diverse stakeholders around a shared vision, aligning execution across silos, and ensuring strategies translate into tangible results.
• You excel at influencing senior leaders and driving decision-making in highly matrixed environments, guiding teams through complexity and enabling the organization to adopt new approaches that improve speed, quality, and impact.

Responsibilities

• 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 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.
• 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.
• 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.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed here: Benefits
• Relocation benefits are not available for this position

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level