Senior Medical Director

Company Overview

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.

Relying on deep therapeutic area expertise, scientific knowledge, and a superior understanding of Medical Affairs and the compliant interplay with commercial brand teams, this role is responsible for leading the strategic development and overall tactical execution of dedicated late‑stage pipeline launch, as well as all current on‑market indications with focus on Nephrology. This position is highly visible, collaborative, and influential and will serve as the integrated medical affairs representative for cross‑functional senior leadership teams including but not limited to:
Commercial Brand teams, Clinical Development, Government Affairs, Marketing, as well as developing and advancing relationships with select external KOLs. This individual will report to the head of Medical Affairs.

• Develop, prioritize, and execute the overall US medical therapeutic area strategy including the annual monitoring and adaptations required from integrated learnings across both medical and brand teams
• Develop and execute the strategic direction for responsible therapeutic area within medical affairs including but not limited to the development of publication evolution, evidence generation priorities, medical education assessment, annual plan and key areas of interest, field message evolution and advancing the scientific narrative in close collaboration with the corresponding internal medical affairs functions
• Maintain a superior degree of awareness of clinical landscape, guidelines, scientific literature and competitive threats
• Build and advance identified priority external relationships with senior KOLs and physicians who are clinical leaders and influencers to form a relevant and sustainable strategy reflective of patient, payor, and other US customer needs
• Present disease state and clinical data to a variety of internal and external audiences (e.g., government, policy, payors, etc.)
• Oversee and manage execution of scientific Review and input for relevant medical review committees
• Oversee and manage execution of scientific review and input for relevant promotional review committees
• Work with medical information to triage the handling of escalated Medical Information Requests including providing research and language to include in the development of SRLs
• Provide input and support for field medical initiatives and execution as required from MSL lead
• Consolidate and share integrated insights with other functions within R&D (eg: clinical development, regulatory)
• Primary partner to Commercial team for the education and training of speakers on disease state and clinical data promotional presentations
• Ensure continuous development and training of the medical affairs and MSL team with regards for disease area expertise

• Advanced Scientific degree, MD/DO preferred, with 10‑12 years of progressive medical or scientific affairs experience within the pharmaceutical or biotech industry or equivalent experience
• Superior pharmaceutical industry experience within Medical Affairs
• Demonstrated advanced understanding of relevant connections and integration points between Medical Affairs and stakeholders across the R&D and Commercial functions
• Superior experience working in a complex matrix management environment
• In‑depth knowledge of study methodology, data analysis techniques, and critical review of publications is strongly preferred
• Strategic mindset with a focus on collaboration and excellence
• Superior organizational skills including…