• Lead the Clinical Trial Team (CTT) and Trial Management (TM) team
• Define and align CTT goals collaboratively with the team
• Review and approve protocol and amendment changes
• Review the Master Informed Consent Form (ICF)
• Approve operational plans, manuals, and charters for the trial
• Oversee the vendor selection process
• Initiate and verify the accuracy and completeness of initial Work Orders (WO) and Change Orders (CO)
• Guide the country selection process
• Coordinate responses to IEC/IRB comments
• Monitor major protocol deviations (PDs) and trends
• Approve data cleaning plans
• Collaborate with CPL as needed for CST/CDT
• Establish and maintain clear responsibility distribution
• Review and contribute to the CSR as needed
• Escalate issues to CPL in a timely manner
• Execute operational strategies related to drug supply, regulatory submissions, and recruitment

• Assist in the initial development and management of the trial budget
• Plan, implement, and maintain detailed, integrated trial timelines from the study outline through CSR
• Develop initial recruitment projections and strategy
• Approve updated recruitment projections in alignment with CPL
• Serve as the counterpart for CRO PL/PM, approving the CV of PL/PM

• Identify study risks with the CTT and oversee risk management activities
• Maintain and oversee the CTT issue log and ensure timely issue resolution
• Ensure CTT action and decision logs are up-to-date
• Support audit preparation and responses
• Implement Corrective and Preventive Actions (CAPAs), if applicable

• Bachelor's or Master's degree with relevant specialization; Master's degree preferred
• Minimum requirement: 5+ years in clinical operations
• Significant experience leading clinical projects
• Experience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teams
• Some experience with operational management and budget planning
• Proven performance in earlier role/comparable role

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so