Global Strategic Lead

Description

Strategic Leadership:

• Lead the development of Medical Product Strategy (MPS) ensuring CDx strategies and tactics are represented in the Core Medical Plan (CMP) for the relevant product
• Contribute to creation of Integrated Evidence Generation Plan (iEGP) with cross-functional experts, serving as the strategic foundation for evidence generation
• Define and oversee overarching objectives with medical KPIs, ensuring alignment with global and local Strategies

Medical Affairs Excellence

• Lead a high-impact team with accountability for delivery of CDx/PM evidence generation and dissemination tactics in the CMP for the relevant product, ensuring seamless execution that balances global objectives with local needs and adaptability. Accountable for budget management associated with evidence generation and dissemination tactics executed globally
• Empower & enable affiliates to deliver on CDx/PM non-evidence generation and dissemination tactics of CMP for the relevant product, whilst encouraging iterative dialogue to address local needs
• Ensure robust governance and review of synopsis/protocols of all CDx/PM MA sponsored studies maintaining high standards for evidence generation
• Accountable for implementation of the Integrated Evidence Dissemination Plan with strong scientific messages to support CDx. Ensure provision of centralized resources and iterative feedback to refine scientific messaging
• Enable the execution of the CDx/PM tactics of the Global launch plan for relevant product, providing KPIs and metrics to track global progress
• Support internal and external medical education needs for CDx/Biomarkers in new disease areas/innovative treatment modalities with biomarker and CDx requirements

Qualifications

• A medical degree (MD or equivalent) or Doctorate degree in Pharmacy or Pharmacology recognized by one of the leading governing bodies from around the globe

Experience And Expertise

• Minimum 10+ years of progressive leadership experience in Pharmaceutical Medicine including 5 years in the CDx/PM space; preferably in Medical Affairs within the pharmaceutical industry/diagnostic company or alternatively in a commercial laboratory or academic institution.
• Expertise in leading cross-functional and geographically diverse matrix teams while delivering high-impact business results. The ability to influence without direct authority is a critical skill set for this role.
• Demonstrated success in leading the brand medical affairs strategy, including product launches and lifecycle management
• Strong ability to develop innovative, patient-centered medical affairs evidence generation and dissemination strategies that drive patient access and brand performance
• Strong understanding of industry trends, the regulatory environment, as well market access paths for CDx
• Has advanced understanding of rules and regulations in pharma, including knowledge of global regulatory bodies and procedures, as well as anti-kickback laws, which could have impact for the pharmaceutical industry. Appropriate knowledge of guidelines and regulations such as IFPMA (International Federation of Pharmaceutical Manufacturers Association), PhRMA (Pharmaceutical Research and Manufacturers of America), FDA, EMA, PMDA, ACCME and OIG. Is able to apply legal and compliance knowledge to Medical Affairs activities
• Experience in managing large budgets with demonstrated ability to apply proactive risk management on budget and timelines