JOB DETAILS

Job Description PURPOSE OF JOB/POSITION Lead as point of excellence on patience access matters in Growth & Emerging Markets (GEM) medical teams to ensure expanded access to treatments for patients in need with sustainability.
Drive patience access strategic planning, framework development and implementation of patient access and risk management models, including non-trial pre-approval access programs Drive systematic risk management in medical affairs by close business partnering to ensure risk preparation, monitoring and mitigation.
ACCOUNTABILITIES Patient Access & Risk Management Drive strategic planning and devleop operating model with guidance for all GEM patience access programs and mechanisms (eg.
IPR, NPP, IRUP, etc).
Develop and implement capability building both internally and externally to address patient access barriers and establish Takeda as a leader in global healthcare.
Partner with stakeholders and teams to ensure successful implementation and execution of GEM patient access operation model.
Partner with TA teams on input to global Holistic Access Plans (HAP) per product, on topics in relation to GEM operations and planning for patience access.
Development training and communication plans to build awareness and understanding of patient access programs and initiatives to key stakeholders within the region.
Communicate and train teams on patient access principles and policies within and across the organization to support a patient centric culture.
Partner with stakeholders such as ATM, global HEPA, legal, Pharmacovigilance and others to ensure GEM patience access operations alignment with other function’s responsible mechanisms (eg.
Compassionate use, etc) Perform periodic review and revision on GEM patience access operating model and strategic planning to align with organizational aspirations on providing access to treatments.
Develop holistic regional risk management plans in partnership with global and cross-functional stakeholders for patient access.
FUNCTIONAL KNOWLEDGE Critical functional knowledge Demonstrated understanding of Medical Affairs purpose, patient access and risk management Demonstrated understanding business context and regulatory and legal environments related to patient access and risks.
Deep understanding of access to treatments, expanded and/or early access mechanisms and related policies, as well as risk management.
Understanding of global regulations related to expanded access Project management experience related to expanded access, including Ability to build consensus across multiple functional stakeholders Vendor management/oversight and experience working with supply chain Budget management and drug supply forecasting Strong skills and knowledge in GCP, quality and/or clinical development.
CAPABILITIES Critical technical, professional and personal capabilities Bachelor’s in science or related field required Advance degree in science or related field preferred Minimum 8 years of experience in medical affairs, above country level experience is a plus.
Experience in patient access, risk management and/or medical governance.
Critical leadership capabilities High strategic enterprise thinking capabilities, holistic view on patient access and risk management for the organization.
Ability to manage global and complex situations and quickly adapt to changing dynamics.
Ability to influence others in matrix setting to achieve alignment and consensus Ability to work in a cross-functional, cross-cultural, and competitive business setting Demonstrating excellent listening and decision-making skills Excellent written and oral communications, and presentation skills Self-driven and clear track record of results delivery Proven skills as an effective team player who can engender credibility and confidence within and outside the company