Global Patient Access Strategy Lead

Role Summary

Global Patient Access Strategy Lead — provide strategic leadership to ensure successful planning and implementation of Patient Access programs. Lead and develop the strategy for planning, coordination and execution of Patient Access programs and initiatives. Develop and implement training and communication plans to build awareness, engagement and support for patient access programs and initiatives across the organization.

Responsibilities

• Lead strategic planning and drive execution of pre-approval access programs, leveraging AI tools and data-driven decision making, in collaboration with the Global Product Team, Regional and LOC teams
• Represent Global Patient Access on cross-functional teams to define approaches and strategies related to Patient Access
• Serve as a main point-of-contact with project and functional teams regarding Patient Access programs and report progress on achievements within the strategic areas of focus
• Collaborates closely with cross-functional, global and local teams (e.g. Medical affairs, Clinical supplies, R&D) on the planning pre-approval access programs
• Responsible for education and training cross-functional teams (Global, Region, LOC) on Patient Access programs, policies, and SOPs
• Manage budget planning for Patient Access programs
• Maintain awareness of worldwide Regulatory guidance and support implementation of best practices related to Patient Access across Takeda
• Collaborate closely with other Patient Access teams (e.g. Oncology) and provide support for other Patient Access mechanisms and initiatives as needed
• Support audits and inspections related to Patient Access
• Support and contribute to process enhancement initiatives
• Manage relationships with key external partners and vendors
• Participate in other activities, teams and committees as assigned

Qualifications

• Required: PhD, PharmD with ~5+ years; MS with ~8+ years; BS with ~10+ years experience or related experience in clinical research or pre-approval access in the pharmaceutical industry or CRO
• Desired: Advanced degree in a Health science field preferred (e.g. Nursing, Pharmacy, Public Health).
• Desired: Previous experience managing pre-approval access programs
• Desired: Comfort with emerging technologies and adaptability to digital tools
• Desired: Proven ability to integrate AI and technology solutions into strategic planning and execution of patient access programs
• Desired: Thorough knowledge of global regulatory requirements and guidance related to Patient Access

Skills

• Strategic planning
• Cross-functional collaboration
• Education and training program development
• Regulatory awareness
• Budget management
• Stakeholder management
• AI and data-driven decision making

Education

• PhD or PharmD or MS/BS with relevant clinical research/pre-approval access experience

Additional Requirements

• Hybrid work arrangement in Boston, MA may apply