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.
The Senior Clinical Trial Manager (Senior CTM) provides strategic and operational leadership for the execution of clinical trials across one or more clinical programs. This role is responsible for overseeing end-to-end study delivery from planning through close-out, ensuring studies are conducted ethically, on time, within budget, and in compliance with applicable regulatory requirements and Good Clinical Practice (GCP). The Senior CTM serves as a key operational leader, proactively managing risk, mentoring team members, and partnering cross-functionally to support program success while maintaining patient safety and data integrity.
Responsibilities:
- 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
Qualifications:
- 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 full-time position is $163,000 - $190,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
