Associate Director, Medical Training and Data Management
ArdelyxAbout the role
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:The Associate Director, Medical Training and Data Management serves as the medical subject matter expert for training Medical Science Liaisons on disease state landscape, clinical data, and relevant literature as needed. This individual will also help to identify and resource non scientific training in conjunction with the medical affairs leadership team (MALT). Additionally, this role is also responsible for supporting both the Promotional Review Committee (PRC) and Medical Review Committee (MRC), providing clinical and scientific guidance to ensure that all promotional and non-promotional materials are scientifically accurate, balanced, and evidence-based.This role operates with an enterprise-wide mindset, balancing scientific rigor with practical, risk-based solutions to enable compliant and effective business execution. The Associate Director is expected to partner cross-functionally to identify inaccuracies or inconsistencies in data, potential risks with options or pathways to move forward mitigating those risks, work collaboratively , ensuring alignment between medical integrity and organizational objectives.This role requires extensive pharmaceutical industry experience, strong scientific acumen, deep knowledge of promotional regulations, scientific evidence evaluation, cross collaborative approach and superior communication skills.Responsibilities:- 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 promoti
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