DescriptionPosition Summary:Reporting to the Chief Medical Officer, the Vice President, Clinical Development will play a critical role in shaping and executing Ardelyx's clinical development strategy across current and future pipeline programs. This individual will serve as a key clinical leader within the organization and will partner closely with Medical Affairs, Clinical Operations, Biostatistics, Safety/Pharmacovigilance, Regulatory Affairs, Translational Medicine, and Business Development.
The Vice President, Clinical Development will initially serve as a highly hands-on individual contributor responsible for advancing ongoing and planned clinical programs, with a particular focus on supporting pediatric development activities in gastroenterology and broader pipeline initiatives. As the organization continues to grow, this individual will have the opportunity to build and lead a broader clinical development organization over time.
Responsibilities:- Lead clinical development strategy and execution for ongoing and future clinical programs
- Serve as the clinical lead for pediatric development activities and support the successful execution of pediatric clinical programs.
- Design and oversee clinical studies, including protocol development, medical monitoring, data interpretation, and clinical trial execution.
- Develop clinical development plans aligned with Target Product Profiles, regulatory requirements, and broader corporate objectives.
- Partner closely with Clinical Operations, Biostatistics, Safety/Pharmacovigilance, Regulatory Affairs, Data Management, and Translational Medicine to ensure timely and high-quality program execution.
- Contribute to the development of early- and mid-stage protocols for future pipeline or business development opportunities.
- Lead and support the preparation of key clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, INDs/CTAs, briefing documents, and responses to regulatory agencies.
- Participate in interactions with regulatory authorities, key opinion leaders, advisory boards, investigators, patient advocacy groups, and other external stakeholders.
- Build and maintain strong relationships with investigators and KOLs to support scientific exchange, clinical strategy, trial execution, and future pipeline development.
- Collaborate with Medical Affairs on scientific communication strategies, publication planning, congress activities, and external engagement.
- Partner with research and translational teams to support biomarker strategy and translational development activities.
- Contribute strategic and clinical insight to business development evaluations and future pipeline opportunities across a range of therapeutic areas.
- Help shape and scale Ardelyx's evolving clinical development organization, with the opportunity to build and mentor a team as the company grows.
- Foster a collaborative, accountable, and patient-centered culture grounded in scientific rigor and operational excellence.
Qualifications:- MD or equivalent required.
- Approximately 5-10+ years of clinical development experience within the biotechnology and/or pharmaceutical industry.
- Experience leading or contributing meaningfully to late-stage clinical development programs and regulatory submissions.
- Early-stage development experience, including protocol design and development planning, is highly valued.
- Prior experience serving as a clinical lead on clinical trials, including protocol development, medical monitoring, and interpretation of clinical data.
- Experience working across a range of therapeutic areas will be viewed favorably
- Pediatric development experience is not required.
- Demonstrated understanding of clinical trial methodology, drug development processes, and regulatory requirements.
- Proven ability to work effectively in cross-functional matrix organizations and collaborate closely with functions including Clinical Operations, Biostatistics, Regulatory Affairs, Safety, and Medical Affairs.
- Experience in small or mid-sized biotechnology companies is highly desirable.
- Demonstrated ability to operate effectively in a hands-on environment with limited infrastructure and evolving organizational needs.
- Strong communication and presentation skills, including the ability to effectively engage internal leadership, investigators, KOLs, and external stakeholders.
- Experience contributing to translational medicine strategies and/or biomarker-informed development approaches is a plus.
Location: Ardelyx has offices in Newark, CA, and Waltham, MA. Candidates should be able to work from either office two days per week.
The anticipated annualized base pay range for this full-time position is $360,000-$455,000. 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 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.
