Objectives/Purpose
- Provide strategic leadership to ensure successful planning and implementation of Patient Access programs.
- Lead and develop the strategy for the 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.
Accountabilities
- Lead strategic planning and drive execution of expanded access programs 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 the main point of contact with project and functional teams regarding Patient Access programs and report progress on achievements within the strategic areas of focus.
- Collaborate closely with cross-functional, global, and local teams (e.g., Medical Affairs, Clinical Supplies, R&D) on planning expanded access programs.
- Responsible for educating 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 the implementation of best practices related to Patient Access across Takeda.
- Collaborate 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.
- Contribute to process enhancement initiatives.
- Manage relationships with key external partners and vendors.
- Participate in other activities, teams, and committees as assigned.
Core Elements Related to This Role
- Experience planning and executing expanded access/Compassionate use programs.
- Thorough knowledge of global regulatory requirements and guidance related to Patient Access.
Dimensions and Aspects
- Ability to improvise and demonstrate creativity in solving problems and achieving objectives.
- Ability to analyze complex situations, make decisions, and plan for the future.
- Comfortable with ambiguity and has the ability to work independently, take initiative, and complete tasks in a timely manner.
- Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions (e.g., Medical Affairs, Global Manufacturing & Supply, Ethics and Compliance).
- Strong proven ability to collaborate cross-functionally and build consensus.
- Excellent written, oral communication, and presentation skills.
- Must be able to work in a fast-paced environment with a demonstrated ability to simultaneously manage multiple competing tasks and demands.
- Experience in Project Management.
- Experience working with supply chain, vendors, and external organizations (including corporations, associations, non-governmental organizations, and academic institutions) relevant to patient access and global healthcare.
- Experience working within a complex, global organization and demonstrated ability to work across functions and regions without direct authority.
- Ability to influence and work effectively with various disciplines and functional areas.
- Good working knowledge of MS Word, Excel, PowerPoint, and Outlook.
Education, Behavioral Competencies and Skills
Required:
- PhD, PharmD with ~3+ years; MS with ~6+ years; BS with ~8+ years of experience or related experience in clinical research or expanded access in the pharmaceutical industry or CRO.
- Previous experience managing global expanded access programs.
- Requires approximately 10% travel, including overnight and international travel to other Takeda sites and meetings with external partners.
Desired:
- Advanced degree in a Health science field preferred (e.g., Nursing, Pharmacy, Public Health).
Apply online using the form below. Only applications matching the job profile will be considered.