Ardelyx, Inc. · 2 days ago
Associate Director, Nonclinical Development
Newark, CA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$205K/yr - $251K/yr
7+ years expArdelyx, Inc. is a publicly traded commercial biopharmaceutical company focused on developing innovative medicines for unmet medical needs. The Associate Director of Nonclinical Development will design and implement nonclinical strategies to advance drug candidates, overseeing GLP safety studies and collaborating with cross-functional teams.
BiotechnologyHealth CareMedical
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
Qualification
Required
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
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
Ability to work effectively with cross-functional R&D colleagues
Preferred
Experience conducting or overseeing nonclinical studies with small and large molecules
Experience as a supervisor is a plus
Benefits
401(k) plan with generous employer match
12 weeks of paid parental leave
Up to 12 weeks of 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
At least 11 paid holidays
Company
Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.
201-500 employees
H1B Sponsorship
Ardelyx, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$557.68MKey Investors
HealthCare Royalty PartnersSLR Capital PartnersNew Enterprise Associates
2022-06-30Post Ipo Debt· $20M
2022-02-24Post Ipo Debt· $27.5M
2019-12-12Post Ipo Equity· $125M
Leadership Team
Mike Raab
President & CEO
David Rosenbaum
Chief Development Officer
Recent News
2026-01-03
New Enterprise Associates
2025-12-02
2025-11-21
Company data provided by crunchbase