The Global Program Leader is fully-dedicated and responsible for an overarching Global Program and leads all development and LCM projects associated with an asset from discovery to the marketplace. The GPL leads the Global Project teams (GPT) and ensures linkage to all sub-teams, e.g., Discovery, Cell Therapy Product Development, Translational, Clinical, Global Brand Team, Market Access etc. to ensure all project deliverables achieve defined project scope, budget and timelines. The GPL is the primary interface with Cell Therapy Engine, OTAU, OBU and Senior Management with external partners and is responsible to create the global program strategy and operational plan for an asset to maximize value and to realize Takeda’s overall vision. In doing so, this position will lead and manage a matrix team of people and resources to achieve high levels of performance and improve the overall performance of the Takeda’s Cell Therapy global program portfolio. Program activities include strategy and planning towards milestones, defining clear go/no go criteria for decision points, creating buy-up/buy-down scenario plans, managing critical path activities, proactively identifying issues, resolving conflicts and communicating project-related challenges /issues to senior executive management. The GPL in early phase will lead first-in-human, early clinical and label enabling development plans for novel cell therapies eventually establishing long-range plans and goals for global programs to achieve our Oncology Cell Therapy ambition. The GPL provides leadership and vision for global regulatory submissions and approvals to achieve successful commercialization and new product value optimization.
- Leads the Global Program in setting project/product strategies, goals, priorities and long-term plans and schedules. Builds and aligns cross-functional, cross-divisional project goals with Takeda business needs and strategies.
- Provides strategic, process, and operational leadership to the GPT and Takeda functions in the successful delivery of projects from discovery to commercialization. Cell Therapy Projects will be highly complex with moderate to high project risk in disease areas with evolving regulatory paths across all phases of development.
- Links sub-teams, such as the Redirected Immunity Discovery, Cell Therapy Translational Team, CTE, Global Brand Team, Regulatory team etc. to the GPT through transversal expert leaders/project management functions to align activities and ensure transparency of all project/product-related activity
- Lead clinical and medical related functions, whether internal or outsourced to set clinical strategy for development and lifecycle management plans – optimizing clinical outcomes and benefits
- Oversees clinical trial data analysis, interpretation and regulatory soundness
- Provide disease area and clinical development expertise in support of overall cell therapy strategy
- Supports OTAU/ CTE Leaders and Sub-leaders to set the vision and direction for oncology cell therapy development and prioritizes all aspects of the project within a global program.
- Reports on progress of the project including issues/plans, and critical path schedules to Takeda executive management through internal or external reviews of global programs or projects.
- Visibly advocates and supports key business initiatives: Evaluates new opportunities (i.e.: in-licensing candidates, impact of change in
- market conditions or availability of new project data) and provides overall support for feasibility studies on potential global programs.
- Responsible for project operating budgets within the global program; monitor and control expenditures; manages variance between budgeted and actual expenditures of time, dollars, and personnel while meeting overall Takeda financial objectives.
- Manages internal and external resources (people, information, technologies, time, and capital); allocates project resources appropriately, given division, function and individual goals and objectives to align with business imperatives.
- Proactively identifies project risks before they arise and develops contingency plans; communicates project-related issues to senior executive management and manages issues to resolution.
- Consults with OTAU leads, Functional Leaders and divisional project management functions to deliver accurate and timely project status and deliverable information to enable the organization to focus on key priorities and enhance its ability to deliver work (e.g., studies/projects) on-time and on-budget (including proficient use of systems to improve reporting or access to data).
- Proactively responds to the dynamics of a changing marketplace; directs adjustments in functional or cross-divisional plans in response to changes in strategic direction.
- Contributes to the creation and maintenance of systems/databases for the purpose of applying data analytics to large data sets, tracks key performance indicators (KPIs), monitors trends for improved earning and decision making regarding program performance and continuance.
- Provides matrix management, strategic and tactical leadership to GPT members who are responsible for leading the key deliverables or program sub-teams within individual projects.
- Ensures quality GPT interactions and decision making. Manages performance of GPT members.
- Graduate Degree science or business-related field
- Minimum of 10 years experience in the pharmaceutical industry, with working knowledge of research and development as well as commercial operations
- Minimum 5 years experience with increasingly complex pharmaceutical projects in a multi-disciplinary, global environment including strategy development and execution
- Minimum of 5 years matrix team management in a global environment
- Track record of leading projects to key stage gate milestones
- Interaction with Global Health Authorities
- Broad business orientation is highly preferred
- Managed multiple NME global approvals
- Multi-faceted background with direct involvement or experience working with functions from multiple divisions: Research, Development, CMC, Commercial/Marketing, Global Licensing and Business Development (GLBD)
- Must have an understanding and experience with worldwide Regulatory submissions and approval processes as well as global launch and commercialization requirements
- Expert knowledge in the overall pharmaceutical drug development process, from discovery through post-marketing
- Demonstrated ability to build consensus and drive resolution of issues while maintaining positive working relationships across functions; negotiation and strong persuasive abilities
- Strong written and verbal Communication Skills: ability to express oneself clearly and concisely to external partners, vendors or with others within the team; ability to message key issues appropriately and document issues and/or concerns concisely and comprehensively; ability to adjust language and/or terminology appropriate for the audience; Demonstrated ability to clearly and concisely communicate/present key information to senior management
- Analytical and Problem Solving Skills: ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
- Strategic Implementation: ability to develop, implement and monitor the overall project strategy at TGRD and integrate this strategy with global corporate goals
- Leadership Skills: develops and uses knowledge and interpersonal skills to influence and guide others towards the accomplishment of Takeda’s goals and objectives. Requires the flexibility and tolerance to best manage change and differing opinions with diplomacy and competence
- Ability to drive decision-making within a cross-functional, cross-divisional and cross-cultural, global team structure and requires global mindset and cultural awareness in working with senior leadership in other regions and in managing cross-regional projects
- Knowledgeable in the processes for managing and developing personnel in a cross-functional, matrix-team, global environment with a proven track record
- Knowledgeable in budget and finance processes appropriate to the pharmaceutical industry
- Ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
- Ability to capture knowledge within the cross-functional, cross-divisional global organization; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
- Management of multiple tasks of varied complexity simultaneously
- Ability to work in a demanding environment with aggressive project timelines
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 20-25% travel.