Associate Director, Medical Review and Training

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.
 
Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.
 
We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.

• Provide input and assist in the development of scientific gap analysis, scientific materials and execute scientific training
• Communicate review outcomes and key decisions to Medical Affairs leadership and relevant stakeholders including providing scientific consultation during development of promotional strategies and materials
• Maintain up-to-date knowledge of therapeutic areas, clinical data, treatment guidelines, and emerging evidence
• Deliver MSL training on disease state and clinical trial data including study design, endpoints, statistical interpretation, and clinical relevance
• Develop and maintain core scientific data training materials (slide decks, publications, etc)
• Lead medical review of promotional and non-promotional materials to ensure claims are scientifically valid, balanced, and supported by appropriate evidence
• Evaluate clinical data, literature, and references to confirm accuracy, relevance, and appropriate interpretation
• Partner cross-functionally to ensure communications are medically accurate and align with approved labeling, treatment guidelines, and current scientific knowledge
• Maintain the highest standards of medical accuracy and integrity across all reviewed materials
• Serve as the medical lead within MRC and PRC review meetings, including facilitating productive PRC/MRC discussions by aligning stakeholders around clear, balanced decisions and practical next steps
• Provide medical and scientific guidance during cross-functional review discussions.  Influence cross-functional teams through collaborative problem-solving
• Provide oversight and guidance for digital, social, and omnichannel promotional materials, including emerging formats
• Monitor external scientific developments impacting medical or promotional review
• Apply a risk based, solution-oriented approach to medical review, partnering with stakeholders to enable compliant communications while supporting business objectives.
• Lead continuous improvement initiatives to modernize and optimize medical review processes
• Contribute to continuous improvement of PRC/MRC processes, including cycle time reduction, decision transparency, and stakeholder satisfaction

• Advanced scientific or clinical degree preferred (PharmD, PhD, MD, DNP or equivalent in life sciences), with 8 - 10 years of pharmaceutical industry experience or equivalent experience, including substantial involvement in medical or promotional review
• GI and / or nephrology experience preferred
• Expertise in evaluating clinical literature and interpreting scientific and clinical data
• Strong understanding of medical, legal, and regulatory review processes
• Excellent cross-functional collaboration and communication skills
• High attention to detail and commitment to scientific rigor
• Safeguard the integrity of product information and patient-focused communications
• Support compliant and responsible dissemination of medical and clinical information
• Demonstrated ability to navigate ambiguity and drive consensus across diverse stakeholders
• Enterprise mindset with ability to balance risk, compliance, and business enablement
• Strong executive presence and influencing without authority skills in complex cross-functional environments
• Pragmatic decision maker with a solutions oriented communication style
• Innovative, motivated and proactive mindset approach to the operation of medical affairs