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. This involves overseeing process management, ensuring compliance, monitoring performance, and streamlining vendor decisions and oversight.

• 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.

Who You Are:

• You have a Bachelor or Masters in Scientific, Medical or Healthcare field

• You are seen as an expert, advanced in career with 10+ years of relevant experience in process and/or compliance and/or vendor management and/or systems and learning.

• You have prior experience of the proactive management and development of a team of direct reports

• You exhibit a high degree of autonomy in prioritizing responsibilities with limited oversight, while expertly steering the team in crafting comprehensive strategies to enhance the execution of clinical trial infrastructure projects.

• You have in-depth and broad drug development knowledge and are recognized as a technical expert in Clinical Operations or related areas of expertise.

• You are able to anticipate business, organization, vendor, and regulatory issues and recommend, implement and embed products, processes, and/or service improvements.

• You architect, lead, mentor, and coach high-performing clinical trial or molecule program teams and/or complex enabling projects. Develops an operational strategy for project clinical trial or enabling project execution.

• You lead others in resolving complex or highly complex outcomes that may have cross functional organizational implications and influence senior stakeholders to adopt a new approach.

#ClinOps

The expected salary range for this position based on the primary location of South San Francisco, CA is 188,400-349,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.