Senior Clinical Trial Manager

Overview

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan.

A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.

• Provide senior-level operational leadership for one or more clinical studies or programs, overseeing execution from initial study synopsis through final deliverables, including study start-up, enrollment, conduct, database lock, statistical outputs (TLFs), and Clinical Study Reports (CSRs)
• Serve as the primary operational point of contact for assigned studies, partnering closely with the Study Lead, Clinical Operations leadership, and cross-functional teams
• Lead and oversee study start-up activities in collaboration with CROs and investigational sites, including strategic oversight of clinical document development, site activation, and readiness activities
• Drive study execution to ensure adherence to timelines, milestones, budgets, and quality standards; proactively identify operational risks and develop mitigation and contingency plans
• Provide oversight, review, and approval of study-related documents, including Informed Consent Forms (ICFs), CRFs, Monitoring Plans, Laboratory Manuals, Pharmacy Manuals, Patient Diaries, Clinical Site Procedures Manuals, and CRF Completion Guidelines
• Oversee CRO and vendor performance, including selection support, contract scope review, governance, issue escalation, and performance management across central laboratories, EDC/IRT providers, and specialty vendors (ePRO, ECG, imaging, etc.)
• Lead and/or support user acceptance testing (UAT) and validation activities for clinical systems, contributing to system requirements and ensuring readiness for study conduct
• Ensure inspection readiness and compliance with GCP, ICH guidelines, applicable regulations, SOPs, and study-specific procedures; support audits and regulatory inspections as needed
• Develop, maintain, and present detailed study dashboards, metrics, and risk assessments; communicate study status, issues, and mitigation strategies to senior management and governance committees
• Mentor and provide functional guidance to Clinical Trial Managers, Clinical Trial Associates, or other study team members, contributing to team development and operational excellence
• Represent Clinical Operations internally and externally, building strong relationships with investigators, CROs, vendors, and cross-functional stakeholders

• Bachelor’s degree in Life Sciences, Nursing, or a related field with 7–10+ years of clinical research experience, including significant hands-on clinical trial management responsibility; equivalent experience may be considered
• Master’s degree and clinical research certification (e.g., CCRA, CCRP) strongly preferred
• Demonstrated expertise in clinical trial operations, GCP, ICH guidelines, and global regulatory requirements
• Proven ability to lead complex, multi-site and/or global clinical studies across multiple vendors
• Strong strategic and operational project management skills, including budget oversight and resource planning
• Excellent leadership, communication, and stakeholder management skills, with experience influencing cross-functional and external partners
• Advanced problem-solving skills and the ability to manage ambiguity and competing priorities
• Proficiency with clinical trial systems and tools, including EDC, IRT, and eTMF platforms
• Willingness to travel occasionally to clinical sites, investigator meetings, and professional meetings as required
• Remote work considered; preference for candidates able to attend the office weekly (Fremont or Boston)

The anticipated annualized base pay range for this…