POSITION SUMMARY:

ALX Oncology seeks a dynamic leader with a proven track record of success in Clinical Operations. Reporting to the Chief Medical Officer, the Vice President, Clinical Operations, will be the senior leader responsible for overseeing all aspects of clinical trials and development programs, ensuring compliance, managing budgets and timelines, and leading a team of clinical operations professionals. They will play a crucial role in translating drug development strategies into operational excellence, connecting science with business objectives and patient needs

QUALIFICATIONS AND SKILLS:

• BS (Science Degree) with 15+ years, MS/RN/PharmD with 8+ years
• Broad and deep knowledge of clinical operations, clinical development, and clinical project management.
• Proven track record of leading clinical operation teams for early and late-stage clinical development programs.
• Experience with CRO management.
• Experience with clinical trial audit activities.
• Expected competencies:
• Working knowledge of ICH/GCP guidelines.
• Effective written/verbal communication.
• Ability to work independently as well as collaboratively in a multidisciplinary setting.
• Flexibility and willingness to adapt in a changing environment.
• Ability to travel.
• Travel may be required up to 25% of your time.
• This position will be located in South San Francisco, CA.

• Provide strategic direction for outsourcing, selection, and oversight of CROs and provide ongoing executive management to selected partners.
• Develop and continuously monitor study timelines, study progress, study costs, and resource allocations. Implement corrective action when deviations occur; work with functions to develop contingency plans and drive their implementation when triggered.
• Oversee the preparation and management of clinical trial budgets. Support Finance and Corporate Development to forecast estimated costs for potential studies. Liaison with Clinical and Finance teams to review CRO budgets, change orders, invoices, and to approve payments.
• Serve as the Clinical Operations representative for internal governance meetings including cross-functional Project Team and Protocol Review Committee.
• Interact collaboratively with Quality, Regulatory, CMC, Finance, and Clinical teams to ensure operational excellence in clinical trial execution to ensure compliance with GCP and ICH guidelines and financial reporting requirements.
• Support development of SOPs and establishment of associated training for teams and ensure operational excellence in clinical trial execution to ensure compliance with GCP and ICH guidelines and financial reporting requirements.
• Work with internal team members to ensure compliance with all domestic and foreign regulatory requirements governing the conduct of clinical trials on human subjects.
• Forecast resourcing requirements to meet the needs of current and projected study activities.
• Provide line management of direct reports including performance management and coaching/development