Sr. Clinical Systems Leader

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The Senior Clinical Systems Leader (CSL) is responsible for leading and optimizing the clinical systems used in the development of clinical trials within Early Clinical Development (ECD). The Senior CSL works closely with key stakeholders and collaborates with colleagues across Roche/Genentech to streamline processes, identify synergies, and maximize efficiency. Your primary responsibility as a Senior CSL will be to provide strategic, technical, and operational leadership for the design, implementation, and lifecycle management of clinical systems, including but not limited to Interactive Response Technologies (IRT/IxRS) and electronic Clinical Outcome Assessments (eCOA) across the ECD portfolio at both study and program levels. You will serve as both the visionary and execution leader for clinical systems support activities, aligning with the ECD Leadership Team and partnering across Roche/Genentech business units to ensure system strategies align with both short-term and long-term technology and process roadmaps.

The Opportunity:

• Accountable for guiding, planning, and implementing all clinical systems (e.g., IxRS/eCOA) activities for the ECD portfolio.

• Collaborate with a cross-functional team of internal stakeholders-including but not limited to Clinical Operations, Biostatistics, Clinical Supply Chain, Data Management, and Procurement-and clinical systems vendors to ensure successful implementation and maintenance of technology solutions supporting clinical trials.

• Lead project management activities, covering all aspects from specification, development, user acceptance testing, and implementation to training, enhancement, and closeout.

• Provide strategic and operational leadership during system requirements gathering meetings with study teams and clinical systems vendors.

• Proactively identify and track study/program-level technical issues through to resolution. Ensure timely resolution of system issues, document issues and risks, and implement mitigation plans in collaboration with study teams and vendor project managers.

• Collaborate with Procurement Delivery Managers on vendor assessments, RFIs, and selections at the study and program level. Actively engage in issue escalation, monitor vendor performance, and participate in system squads/governance committees as needed.

• In collaboration with Clinical Systems Group Leadership, routinely review key performance indicators (KPIs) and metrics related to system issues-including issue volume, severity, and resolution turnaround time and recommend continuous improvement initiatives.

• Act as or support the Program Systems Lead (representing gRED) in developing program-aligned IxRS and eCOA strategies and standards. Collaborate with the program leader and engage with iCOP to determine program-specific requirements, ensuring implementation of enterprise level standards and development of program level standards throughout the program lifecycle.

• Lead and establish a program-level systems community across all business units to foster a support network within the disease area and ensure consistent application of program-aligned requirements across all studies.

• Serve as a recognized and influential subject matter expert in clinical systems within gRED and Pan-Roche. Represent gRED and ECD in cross-functional projects, committees, and governance.

• Partner with colleagues across Roche/Genentech to simplify and streamline processes, identify synergies, and promote best practices within teams and programs.

• Build strong relationships and maintain effective communication with Clinical Operations, Clinical Science, and other functional departments.

• Actively share insights, best practices, and lessons learned across Roche/Genentech teams to foster knowledge exchange.

• Apply strong technical expertise and skills to find opportunities for innovation, efficiency and simplification with the mindset of working smarter.

• Provide mentorship and support to junior staff and study teams.

Who You Are:

• Bachelor's Degree in life science, computer science, engineering, information system, data science or related discipline

• At least 7 years of experience in Clinical Operations, or Clinical Systems Management

• At least 6 years of IxRS/IRT and clinical-related systems experience

• Successful track records in leading the implementation of clinical systems, such as IxRS/IRT, ePRO, and eCOA

• Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution

• Track record of establishing successful partnerships across the organizations

• Excellent written and verbal communication skills and strong project management skills

• Familiar with documentation in a regulated environment. Experience in Veeva is a plus

Relocation benefits are not available for this posting.

Onsite presence, on our South San Francisco campus, is expected for at least 3 days a week.

The expected salary range for this position based on the primary location of South San Francisco, California is $143,100 - $265,700. 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 at the link provided below.

Benefits

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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.

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