Director, Analytical Development
Director, Analytical Development
Posted on :
05-08-2025
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1 Vacancy
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Job Description
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 Director Analytical Development will be responsible for analytical activities across a portfolio of programs at Ardelyx involving clinical and commercial drug substance and drug product.
Responsibilities:
- Develop and lead execution of analytical strategies; prepare RFPs select partners and manage the successful execution of plans consistent with objectives and compliant with cGMP requirements
- Establish resource plans and operational budgets to meet corporate and departmental objectives
- Effectively integrate Analytical Development activities with those of sister CMC functions including Drug Substance Pharmaceutics Supply Chain Quality Assurance and Regulatory Affairs
- Lead the preparation of analytical content for various regulatory documents (IND NDA etc.) and effectively represent the Analytical Development function in interactions with regulatory authorities
- Effectively and professionally represent the Analytical Development function and when needed the broader CMC function on various cross-functional teams including internal project teams as well as external steering and operating teams with contract manufacturing and/or corporate partners
Qualifications:
- B.S. in chemistry or related discipline with 12 years of industry experience or equivalent experience
- Strong experience required in analytical development and associated regulatory requirements
- Experience working in close collaboration with technical regulatory quality assurance project management legal finance and supply chain functions preferably in a cGMP operational environment
- Experience in leading and managing outsourced development efforts and associated operating budgets
- Experience in preparing and defending regulatory documents including briefing books for regulatory meetings INDs and NDAs
- Excellent communication skills and the ability to present to diverse internal and external audiences are requisite
- Periodic travel to manufacturing and other partner sites is required (approximately 10-20 % of time)
The anticipated annualized base pay range for this full-time position is $203000 to $249000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry 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 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.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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