Associate Director, Clinical Operations

Ardelyx•Newark, CA

About The Position

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.

Requirements

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
Ability to engage and foster collaboration, influence others and integrate functions, teams, people, processes, and systems to drive results

Nice To Haves

Experience with Smartsheet is a plus

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