Jobs and Careers

Executive Director, Clinical Operations

United Statesfull_timeVerifiedPosted 13 Nov 2025

💰 $346,000/yr($282,000/yr – $346,000/yr)

About the role

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.

Position Summary:

The Executive Director, Clinical Operations will oversee the Clinical Trial team, including all clinical trial personnel. This role will act as liaison to the Data Management, QA, and CMC teams. This position will maintain effective communication with the team and all Clinical Operations service providers. The incumbent will work closely with the Clinical Program Management team, with CROs and clinical vendors to ensure that all assigned operational trial deliverables are met according to established timelines, budget, operational procedures, quality standards, SOPs and business guidelines.

Responsibilities:

Provide recommendations and implement strategic milestones to ensure optimized clinical development plans for assigned projects
Provide guidance to the Clinical Operations Leads to identify opportunities to optimize and streamline the delivery of clinical trials
Provide direction and leadership in CRO and Vendor selection and management
Establish external best practices and standards of working with Clinical Operations Service Providers including effective communication
Oversee and participate in initial and Vendor Assessments, in collaboration with QA in conjunction with the Clinical Operations Leads and SMEs
Partner closely with cross functional teams including Biostatistics, Data Management, Drug Safety, CMC and Supply Chain, Project Management and Regulatory to optimize operational excellence and improvements
Build, manage, and cultivate high performing clinical teams and mentor new employees
Create and manage the clinical operations budget and ensure clinical projects remain on schedule and within budget

Qualifications:

Bachelor’s degree with 12+ years of related leadership experience in the pharmaceutical or biotechnology industry or equivalent experience
Strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
Direct and control the activities of a broad functional area through partnership with cross- functional department managers within the company
Overall control of planning and strategic innovation; recommend and implement changes to current methods to increase efficiency and reliability
Effective leadership skills and proven ability to foster team productivity and cohesiveness
Strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
Excellent