Position Title: Global Clinical Trial Leader (CTL)
Work Location: South San Francisco, CA, 94080
Assignment Duration: 12 Months
Work Arrangement: Hybrid (three days onsite, two days remote - Tuesdays and Thursdays are anchor days)
Working Days: Monday through Friday
Working Hours: Standard eight (8 AM to 4 PM or 9 AM to 5 PM PT)

Position Summary:
The gRED Global Clinical Trial Leader (CTL) is accountable for the execution and delivery of early development global clinical trials under the leadership of the Sr. CTL. These complex programs focus on the rapid development of new molecular entities with limited or no clinical data, requiring the implementation of novel and highly flexible global operational strategies.

Background & Context:
The role supports The Organization’s Research and Early Development efforts in advancing early-phase clinical programs.

Key Responsibilities:
Study Execution & Team Collaboration
• Operational Expertise: Provide operational guidance to one or more global cross-functional Protocol Execution Teams (PETs) across all study stages (start-up, conduct, and close-out).
• Culture & Leadership: Foster a positive work environment built on mutual respect, innovation, and accountability at both local and global project levels.
• Trial Documentation: Drive and finalize cross-functional activities ensuring the quality delivery of vendor specifications, drug supply forecasting, monitoring/communication plans, Trial Master Files (TMF), and CTMS data.
• Stakeholder Alignment: Collaborate with cross-functional members on study plans and coordinate effective investigator meetings.

Vendor & Budget Management
• Vendor Oversight: Participate in vendor selection alongside the PETL; oversee outsourced activities to ensure CROs and vendors deliver strictly against contracted scopes of work.
• Financial Input: Provide strategic input into the overall study budget and directly manage assigned vendor budgets.

Strategic Planning & Strategy
• Feasibility & Design: Contribute to country and site selection, assist in developing clinical trial protocols/informed consents, and provide operational input on protocol feasibility.
• Risk & Timeline Management: Apply critical thinking to manage timelines, identify bottlenecks, and propose actionable resolutions.
• Patient Centricity: Maintain a patient and site-centric mindset across all trial activities and interactions.

Contributing to the Wider gRED Community
• Process Improvement: Partner with gRED and pan-Roche colleagues to establish operational best practices and enhance clinical trial execution across the organization.
• Subject Matter Expertise: Serve as a Subject Matter Expert (SME) or gRED single point of contact for targeted functional initiatives.
• Mentorship: Coach, mentor, and share expertise to support the development of junior staff and peers.

Qualification & Experience: Technical & Professional Experience
• Early Phase Expertise: Proven experience managing delegated aspects of global, complex Phase I and II clinical studies.
• Vendor Management: Demonstrated success effectively managing a diverse portfolio of vendors and CROs.
• Risk & Strategy: Adept at identifying, assessing, and proactively mitigating operational risks using quantitative and qualitative data.

Leadership & Soft Skills
• Communication & Influence: Excellent communication skills with the ability to independently deliver key messages to stakeholders, influence teams, and negotiate to achieve shared goals.
• Problem Solving: Creative problem solver who welcomes diversity of thought to navigate through ambiguity and resolve issues.
• Adaptability: Highly flexible, solution-focused, and self-aware, exercising excellent judgment on when to seek guidance.
• Change Champion: Consistently advocates for and supports organizational change to positively impact the business.

Qualifications & Requirements
• Education: Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred).
• Experience: 8+ years of clinical study management experience desired.
• Knowledge: Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the end to end drug development process.
• Travel: Some travel may be required.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 85.00/hr.