Job Overview
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.
Essential Functions
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
Key Qualifications
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
Additional Qualifications for Day-to-Day Work
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 meaningful manner with depth of content knowledge.
Understanding of client medical, brand and commercial strategies that are specific with regard to international geography.
Expresses ideas in a clear and concise…