Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early-stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
Guardant Health is looking for a highly motivated and experienced Clinical Program Manager within the Oncology Clinical Trial Operations team. The Clinical Program Manager:
- Drives execution of study contracts between Investigative team and the Guardant Health legal team
- Leads budget review and negotiation. Prepares and/or manages study costs/budget and maintains it within financial goals; reviews and approves invoices against approved budgets
- Develops and maintains dashboards and tools for visibility into contract and budget statuses.
- Effectively communicates with external Key Opinion Leaders (KOLs), Investigators, and biopharma clients collaborating with Guardant Health
- Works cross-functionally with other Guardant Health departments (such as Medical Affairs, Regulatory Affairs, Client Services, Clinical Operations)
- Ensures compliance with applicable regulatory requirements.
- Manages and controls expenses according to Guardant Health policies. Oversees process for Purchase Orders creation, invoice approval, and payments
- Anticipates moderately complex obstacles and difficulties and implements solutions to achieve project goals; displays strong risk assessment capabilities and implementation of mitigation strategies
- Manages operational scope and plans to achieve milestones on-time.
- Identifies barriers to timely and successful study execution and proposes solutions to same, with regular reporting of study performance metrics.
- Bachelor's degree (or higher) in science or health-related discipline
- 8+ years of experience in contracting, budgeting, program management, or clinical trial operations
- Experience on Investigator Sponsored Trials (ISTs), a plus
- Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
- Solid organizational and business assessment skills is required
- Demonstrated ability to develop positive working relationships with individuals and teams internally and externally
- Demonstrated problem-solving skills
- Excellent written and verbal communication skills in English
- Flexible and solution seeking attitude
- Ability and willingness to travel 10%-15% of the time.
- Must have excellent knowledge of MS Office as well as project management tools
- Driven to make a positive impact in cancer diagnosis and treatment
- Detail oriented with an appetite to drive tasks to completion
- Ability to work well in a rapid-pace startup environment
- Ability to work well in a group
- Ability to work independently, with minimal supervision