Description
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 Associate Director, Clinical Operations is responsible for administering all aspects of clinical trials and clinical related systems that support daily activities of cross functional team members. This role has ownership of the clinical technology ecosystem and ensures compliance with all GDP and GCP requirements and oversees Work Instructions and Standard Operating Procedures. The Associate Director manages all clinical systems and the document management team and serves as an important knowledge resource within Clinical Operations.
Responsibilities:
- Lead multiple clinical system risk assessments and system upgrades and act as the Business Owner of clinical systems
- Oversee key platforms such as EDC, IRT, RBQM, eTMF and eISF
- Provide training, mentorship, and development opportunities to members of the clinical operations team as well as outside vendors
- Ensure cross functional needs are implemented as part of new systems while ensuring appropriate quality and validation is being followed
- Work with cross-functional groups to ensure timelines are met to achieve validated, production ready systems
- Oversee system administrators and Document Management team
- Oversee the review, development, maintenance and implementation of TMF Plans, TMF Index, and related Standard Operating Procedures
- Act as a liaison with other managers to assess staff allocation and identify team members available to assist with management of clinical systems
- Work with cross-functional teams to coordinate study related activities
- Lead and implement Clinical Trial Management System (CTMS) and other clinical systems as the needs arise
- Lead integration efforts between Clinical applications as needed
Qualifications:
- Bachelor's degree in biomedical or a related field, or a nursing qualification, with 8+ years of clinical or multi-center studies, including international studies, or equivalent experience
- Advanced Clinical trials and clinical systems experience
- Demonstrated great leadership skills
- Strong understanding of the principles of project management
- Ability to maintain employee confidentiality during interactions with staff
- Strong communication skills with ability to lead projects with remote employees, vendors and CRAs
- Solid computer skills with a working knowledge of Veeva Vault or similar eTMF system, Windows and Microsoft Office, including Excel
- Compliance focused and strong knowledge of ICH E6 (R3), GCP, GxP, 21 CFR Part 11, GDPR, CSV
- Experience with CTMS and eTMF integrations
- Excellent oral and written communication skills, be able to communicate effectively and professionally
- Experience in utilizing a clinical trial management system and ability to train others
- Experience with Smartsheet is a plus
- Ability to engage and foster collaboration, influence others and integrate functions, teams, people, processes, and systems to drive results
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Ardelyx
Feb 18, 2026