Director, Medical Affairs - Real-World Evidence US Lead

Job Description

The Director, Real World Evidence-US Lead, develops and implements RWE strategy to support key activities in the US. The Director works cross-functionally to content expertise and tactical support for the implementation of observational research across the portfolio. This role will be reporting to the head of RWE team at Kite, Executive Director.

Responsibilities

• Develop US RWE plan and strategy
• Lead and support key data generation activities in the US.
• Strategic and tactical support for cross-functional RWE development including registries, burden of Illness/natural history of disease for regulators, payers, and clinicians
• Rotating member of non-interventional study protocol review groups
• Adapt performance metrics and dashboards for RWE project within their therapeutic area
• Assess research gaps and goals across key partners and disease areas to determine proactive RWE/observational research plan in the US.
• Possess superb communication skills, advanced customer experience, comprehensive understanding of strategies to translate observational research methods and results to diverse audiences
• Effectively guide internal and external stakeholder expectations regarding strategic goals and follow through of research

Basic Qualifications

Doctorate Degree and 8+ years of observational research study management or data analytics experience

OR

Master’s Degree and 10+ years of observational research study management or data analytics experience

OR

Bachelor’s Degree and 12+ years of observational research study management or data analytics experience

Preferred Qualifications

• PhD in biostatistics, epidemiology, health economics and outcomes research, health policy, or similar
• Formal training in Epidemiology/Health Services Research
• 5+ years-experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm
• Thorough understanding of the 21st Century Cures Act and the opportunities for use of RWE to inform regulatory decision makers
• Advanced knowledge in observational research design
• Excellent interpersonal communication and study management skills
• Ability to take detailed observational study results and communicate them in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings
• Ability to work effectively in a constantly changing, diverse, and matrix environment
• Excellent working knowledge of the Microsoft Office Suite (Word, PowerPoint, Excel)

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