Associate Director, Medical Training and Data Management
Description
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
Qualifications:
- 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
The anticipated annualized base pay range for this full-time position is $194,000 - $237,000. 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