Director Real World Evidence (N&I) 1

优缺点分析

角色解读

• Career advancement to Senior Director or Vice President of RWE, leading larger global teams and shaping company-wide evidence strategy.
• Opportunity to influence drug development programs at the portfolio level and become a recognized thought leader in RWE methodology.
• Potential transition into broader roles in medical affairs, clinical development, or health economics and outcomes research (HEOR).
• Develop and execute the global real-world evidence strategy for neurology and immunology assets, ensuring alignment with regulatory requirements and commercial needs.
• Lead the design and oversight of non-interventional studies, including external control arms and safety studies, to support drug development and post-marketing commitments.
• Collaborate cross-functionally with clinical, regulatory, biostatistics, and commercial teams to integrate real-world data into evidence generation plans.
• Represent the company in external scientific engagements and maintain partnerships with academic institutions, CROs, and patient advocacy groups.
• + years of experience in pharmaceutical RWE/D, with a proven track record of leading studies from concept to publication.
• Advanced degree in epidemiology, public health, biostatistics, or related field
• deep understanding of RWE methods and regulatory applications.
• Excellent communication and stakeholder management skills to influence decisions across diverse teams.
• Ability to work independently in a fast-paced, global environment while fostering collaboration.

申请策略

• Tailor your cover letter to express passion for patient-centered drug development and how your experience aligns with EMD Serono's mission.
• Research the company’s pipeline in neurology and immunology to discuss how RWE can accelerate development.
• Highlight end-to-end RWE study leadership, especially non-interventional vs. regulatory-grade studies.
• Emphasize experience with integrated evidence planning and cross-functional collaboration with regulatory, clinical, and commercial teams.
• Showcase publications, presentations, and external collaborations that demonstrate thought leadership.
• Quantify impact: e.g., number of studies led, submissions supported, or patient data sources integrated.
• Strengthen knowledge of innovative RWE methods (e.g., external control arms, complex study designs).
• Familiarize yourself with recent regulatory guidance on RWE from FDA/EMA.

面试指南

• Use the STAR method (Situation, Task, Action, Result) to structure responses, emphasizing your role and the impact.
• Demonstrate strategic thinking by linking your actions to broader drug development goals and patient outcomes.
• Show humility and learning: acknowledge challenges and how you adapted.
• Describe a time you led an RWE study that faced challenges in data quality or stakeholder alignment. How did you overcome them?
• How would you develop an integrated evidence plan for a new drug in a competitive therapeutic area?
• What innovative RWE methods have you used to support regulatory submissions? Give an example.
• How do you ensure cross-functional collaboration when priorities conflict?
• Discuss a RWE study you designed that influenced a pivotal regulatory decision.