Sr Director, Medical Evidence Generation Asset Lead (Thoracic)

The Sr Director, Medical Evidence Generation Asset Lead (Thoracic) within the Chief Medical Office organization will serve as a single point of contact between the Oncology Medical Affairs Asset Lead, CMO functional lines and other internal stakeholders to ensure that the medical evidence generation needs of the asset are defined and delivered.

Key Responsibilities

Medical Evidence Generation Strategy & Planning

• Accountable for partnering with Oncology Medical Affairs Asset(s) Lead to develop and deliver the integrated evidence generation plan (IEP) for 1 or more oncology assets
• Acts as single point of contact for Medical Affairs team(s), providing guidance and input on the various research approaches available within the organization
• Orchestrate a multi-disciplinary approach to bridge evidence gaps, leveraging capabilities and expertise across epidemiological, RWE, external patient-centered research
• Leads a cross-functional team of colleagues responsible for developing and executing the asset(s) IEP ensuring appropriate representation from both a functional line and geographical perspective
• 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 all evidence generation activities for assigned assets
• Provide expert input into evidence generation tactical implementation plans throughout the asset lifecycle
• Represent Medical Evidence Generation (MEG) group as Core member of Global Medical Asset Team(s)
• Chair or co-chair Evidence Generation Subcommittees for 1 or more oncology assets, ensuring appropriate strategic and technical review occur for all evidence generation tactics
• Ensure adequate MEG representation for relevant planning and operational review committees (e.g., Program Team, Scientific Publications, etc.)
• Engage Integrated Evidence Planning Success Team to conduct review/refresh of asset(s) IEPs on a regular basis throughout the asset lifecycle, responding to both internal and external environments
• Acts as a champion for identifying and implementing novel approaches to real-world evidence generation activities

Medical Evidence Generation IEP Delivery / Tactical Implementation

• Oversee the overall execution of the IEP evidence generation activities of assigned asset(s)
• Engage MEG 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 MEG and Medical Enablement & Quality team 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 MEG 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 MEG asset reviewer for critical regulatory and select study-level documents as needed
• Represent asset(s) in enterprise and/or therapeutic area evidence generation initiatives

Stakeholder Management

• Responsible for developing and maintaining strong relationships with internal functional line leaders in R&D, Medical and Commercial (as appropriate) organizations
• Serve as point of contact for medical evidence generation activities for external stakeholders including key opinion leaders, external researchers, regulatory agencies (as appropriate)
• Engage Chief Medical Office, R&D, Medical Affairs, Global Access & Value, etc., partner lines regarding strategic issues, project plans, options and recommendations to support efficient and high-quality evidence generation
• Establish and maintain effective communication between global, regional and country-level medical affairs colleagues

Qualifications

• Advanced degree (PharmD, MD, PhD, or equivalent) with 7+ years, MS with 10+ years, or BS with 12+ years of experience in a life science discipline
• Extensive experience in Oncology, epidemiologic and/or infectious diseases research required
• Experience in Oncology clinical development, microbiology and clinical epidemiology preferred
• Expert knowledge of drug/oncology development process
• Demonstrated ability to advise on medical evidence generation strategies
• Experience leading & growing cross-functional teams, strong influence/matrix leadership skills
• 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

Candidate must demonstrate a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Non-Standard Work Schedule, Travel or Environment Requirements

Position requires up to 15% travel including domestic and global travel and flexibility to work across various time zones when necessary.

Work Location Assignment: Hybrid/On Premise