Director, Clinical Systems and Digital Enablement na Ardelyx
Ardelyx · Waltham, Estados Unidos Da América · Onsite
- Senior
- Escritório em Waltham
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 experienced Director, Clinical Systems and Digital Enablement to join our dynamic Clinical team at Ardelyx. Reporting to the Senior Director, Clinical Operations, this individual will be responsible for ensuring scalable, compliant, and future-ready platforms that advance our mission to deliver life-changing therapies to patients. This role will establish ownership of the clinical technology ecosystem, moving beyond system management to a strategic, cross-functional capability that directly impacts development success.
Responsibilities:
- Oversee the design, implementation, governance, and optimization of Ardelyx’s clinical technology ecosystem
- Oversee key platforms such as EDC, IRT, RBQM, eTMF, eISF, and digital enablement tools
- Drive system integration, validation, and lifecycle management, ensuring compliance with global regulatory standards, ICH-GCP, 21 CFR Part 11, and GxP
- Partner cross-functionally with Clinical Ops, Biometrics, Quality, and IT to enable real-time insights and operational efficiency
- Define and implement clinical systems strategy and governance
- Manage and grow a high-performing clinical systems team while managing vendors and budgets
- Drive adoption of risk-based quality management (KRIs, QTLs, CtQs) and centralized monitoring frameworks
- Drive adoption of risk-based quality management (KRIs, QTLs, CtQs) and centralized monitoring frameworks
- Enable real-time data flows and dashboards that accelerate regulatory submissions and support decision-making
Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, or related field (advanced degree preferred) with 9 – 12 years of experience in clinical systems, data management, digital clinical operations, or equivalent experience
- Experience in leadership and/or management roles
- Expertise in EDC, CTMS, IRT, RBQM, Vault Clinical and digital tools
- Strong knowledge of ICH-GCP, GxP, 21 CFR Part 11, GDPR, SDLC/CSV/CSA
- Track record of global systems integration, inspection readiness, and vendor management
- Excellent leadership and communication skills
- Ability to prioritize competing business needs and execute product strategies in a fast-paced environment
- Ability to engage and foster collaboration, influence others and integrate functions, teams, people, processes, and systems to drive results
The anticipated annualized base pay range for this full-time position is $218,000-$270,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual 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 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, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
