Medical Evidence Development Asset Lead; FSP, Sponsor Dedicated

The Medical Evidence Development Asset Lead FSP within the Chief Medical Office organization will oversee Asset-Level Evidence Generation activities and strategy to ensure that the medical evidence generation needs of an asset are strategically aligned and delivered.

1. Medical Evidence Generation Strategy & Planning

• Support the development of the integrated evidence generation plan (IEP)
• Oversee a multi-disciplinary approach to bridge evidence gaps, leveraging capabilities and expertise across epidemiological, RWE, and patient-centered research
• Lead cross-functional team meetings of colleagues responsible for developing and executing the asset(s) IEP
• Engage with all relevant stakeholders (e.g., Medical Affairs, Epidemiology/RWE, Statistics/Programming, Regulatory, Safety, Operations, Quality, Global Access & Value, International, etc.) to ensure comprehensive evidence generation planning is conducted and all tactics are implemented in support of medical strategy
• Guide teams to ensure consistency of approach, appropriate planning and oversight of evidence generation activities for assigned assets
• Provide expert input into evidence generation tactical plans and implementation
• Partner with cross-functional teams to ensure adequate CMO resourcing is available for evidence generation activities
• Conduct review/refresh of asset(s) IEPs
• Acts as a champion for identifying and implementing novel approaches to real-world evidence generation activities

2. Medical Evidence Generation IEP Delivery / Tactical Implementation

• Oversee the execution of the IEP evidence generation activities of assigned asset(s)
• Engage MED Program Management team to coordinate ongoing oversight and tracking of evidence generation activities to ensure timely and quality execution of the medical affairs research agenda
• Partner with MED teams to report on study progress and metrics to R&D, Medical Affairs leadership and other key stakeholders
• Provide input to partner lines on study design and planning to ensure evidence generation activities are feasible and adequately resourced
• Lead and/or participate in early research concept discussions with internal and external stakeholders, as the primary representative from the MED organization
• Proactively and continuously aim to identify and mitigate medical affairs research-related risks and limitations
• Partner with relevant partner lines to find innovative, efficient and timely approaches to achieve Medical Affairs research agenda deliverables
• Act as MED asset reviewer for critical regulatory and select study-level documents as needed
• Represent asset(s) in enterprise and/or therapeutic area evidence generation initiatives

• Direct experience leading the development and execution of
  integrated evidence generation plans; minimum 1 year required, 3 or more years preferred
• Advanced science degree with significant professional experience in real world evidence and life sciences
• Expert knowledge of drug/oncology development process
• Demonstrated ability to advise on medical evidence generation strategies
• Experience across various research methodologies using real-world evidence, observational and low-interventional study designs
• Highly effective verbal and written communication skills with respect to evidence generation planning and decision making
• Strong organizational and project management skills
• Experience engaging with and supporting regulatory-grade real-world evidence projects including contributing to regulatory interactions/correspondences

• Ability to speak in detail with CEOs, COOs, and CMOs about brand, launch and commercial strategy services/solutions, specifically in the life sciences industry segment, in a…