R1 Therapeutics is a California-based (with presence in North Carolina and Boston) clinical-stage biotechnology company dedicated to transforming outcomes for patients living with chronic kidney disease. R1 is building a portfolio of differentiated therapies to address the interconnected complications of CKD—starting with hyperphosphatemia, where unmet need remains high and the standard of care has gone largely unchanged for decades.

The company’s lead asset, AP306, a small molecule, is a first-in-class pan phosphate transporter inhibitor with Phase 2a proof-of-concept and the potential to deliver meaningfully better efficacy with a lower pill burden. R1 launched in 2026 with a $77.5M Series A backed by Abingworth, F-Prime Capital, DaVita Venture Group, and U.S. Renal Care, and is advancing AP306 into Phase 2b with topline data expected in 2027.

Position Description

R1 Therapeutics is seeking a part-time Clinical Trial Manager (CTM) Consultant to support the operational execution of our Phase 2b clinical program for AP306. This is a part-time consulting engagement, estimated at 15–20 hours per week, with the potential to expand as the program advances. The CTM will work closely with the Clinical Operations Clinical Development, CROs/vendors, and other relevant cross functional team members to ensure operationalization in China is being done with high quality and efficiency.

A critical requirement for this role is professional fluency in both English and Mandarin Chinese (spoken and written). R1’s Phase 2b trial includes clinical sites in China, which is being managed by our Chinese Partner and this individual will serve as a key bridge between R1’s U.S.-based clinical team and China Partner. This role is US-based (stateside, California preferred) and does not require relocation.

Key Responsibilities

• Support day-to-day operational management of assigned clinical sites for the AP306 Phase 2b trial, with a focus on operational execution in China
• Serve as the primary R1 point of contact for China Partner, facilitating communication with site staff, principal investigators, and local monitors
• Review and translate (informal, as needed) key study documents and correspondence between English and Mandarin to ensure accurate information flow across the trial team
• Support site initiation activities including site qualification, initiation visits, and training coordination,
• Track and reconcile China specific deliverables (e.g., site start-up, monitoring outputs, data cleaning, TMF documents) within the global study framework
• Monitor enrollment progress and site performance; escalate risks, deviations, and issues to the VP, Clinical Operations in a timely manner
• Review monitoring visit reports, data listings, and site metrics to ensure protocol compliance and data quality at assigned sites
• Coordinate with local sponsor operating in China to ensure alignment with R1 expectations, timelines, and quality standards
• Maintain and update tracking tools, and site status dashboards
• Participate in internal team meetings, investigator meetings, and site teleconferences; provide real-time interpretation or written translation support as needed

Education and Experience Requirements

• 5+ years of clinical trial management experience in the pharmaceutical, biotechnology, or CRO industry, with direct site management responsibility
• Professional fluency in both English and Mandarin Chinese required — spoken and written; ability to conduct scientific and regulatory discussions, translate documents, and communicate with site staff entirely in Mandarin
• Experience managing clinical sites in China strongly preferred; familiarity with NMPA regulatory requirements and China-specific trial operations a plus
• Bachelor’s degree or higher in life sciences, nursing, pharmacy, or a related field required; advanced degree preferred
• Experience in nephrology, cardiorenal, or chronic disease therapeutic areas preferred; willingness to develop deep familiarity with CKD and the AP306 program
• Solid understanding of GCP, ICH guidelines, and FDA/international regulatory requirements for clinical trial conduct
• Experience working with CROs in an oversight capacity; ability to hold external partners accountable to timelines and quality standards
• Proficiency with CTMS platforms, EDC systems, and standard clinical operations tools (e.g., Medidata, Veeva, or similar)
• Strong organizational and communication skills; comfortable managing multiple sites and priorities in a lean, fast-moving environment
• Ability to work effectively as a remote consultant with U.S.-based and China-based teams across time zones

Engagement Details

• Engagement type: Part-time consulting (independent contractor)
• Estimated hours: 15–20 hours per week; hours may flex based on program needs and site activation timelines
• Location: US-based remote work with periodic travel to sites or investigator meetings as needed
• Duration: Initial engagement through Phase 2b topline data (expected 2027), with potential for ongoing relationship as the pipeline grows