Medical Evidence Development I&I Pipeline Asset Lead – (Secondment - 18 Months)

WHAT YOU WILL ACHIEVE

The Medical Evidence Development (MED) I&I Pipeline Asset Lead within the Chief Medical Office organization will serve as a single point of contact between the Inflammation and Immunology (I&I) Medical Affairs team, CMO functional lines and other internal stakeholders to ensure that the medical evidence generation needs of the asset are defined and delivered. 

HOW YOU WILL ACHIEVE IT

Medical Evidence Generation Strategy & Planning

• Accountable for partnering with I&I Medical Affairs Asset(s) Lead to develop and deliver the integrated evidence generation plan (IEP) for 1 or more I&I 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 Development (MED) 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 MED 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 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.

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

Must-Ha