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Associate Director, Nonclinical Development
2 weeks ago
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: We are seeking an Associate Director of Nonclinical Development to join our experienced R&D team supporting drug development programs. The Associate Director will design and implement nonclinical strategies to evaluate and advance Ardelyx's drug candidates through different stages of development. This position involves designing and managing GLP safety studies at contract research organizations (CROs) for early and late-stage programs, analyzing and interpreting safety data, and collaborating with cross-functional teams. Responsibilities:
- Oversee the conduct of nonclinical studies to support Ardelyx programs, including non-GLP and GLP toxicology, pharmacology, and DMPK studies
- Identify/qualify new or existing CROs
- Serve as the Nonclinical representative during GLP audits
- Author and review SOPs and policies related to the Nonclinical function
- Oversee study logistics, including managing contracts with vendors, tracking invoices and payments, and procuring/shipping study materials
- Conduct study monitoring visits
- Review and evaluate study protocols, data, and reports
- Author and review regulatory documents including IND, NDA/BLA, IB, and DSUR
- Prepare and present study updates to internal project teams and senior management
- PhD or advanced degree in toxicology, pharmacology, biology, or related scientific discipline with 7+ years of relevant work experience in the pharmaceutical industry or equivalent experience
- In-depth knowledge and technical oversight of nonclinical toxicology, pharmacology, and DMPK studies
- Experience conducting or overseeing nonclinical studies with small and large molecules is preferred
- Extensive knowledge of GLP principles and FDA/ICH guidelines
- Ability to analyze/interpret complex data and troubleshoot
- Highly organized with excellent written and oral communication skills
- Experience as a supervisor is a plus
- Ability to work effectively with cross-functional R&D colleagues
