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 multiple Global Project teams (GPT) and ensures linkage to Divisional sub-teams, e.g., Global Development Team (GDT), Global Marketing Team, Global CMC team, etc. to ensure all project deliverables achieve defined project scope, budget and timelines. The GPL is the primary interface with TA Unit and Senior Management in CMSO, PDD, PRD, CCO, GLBD and with external partners and is responsible to create the global program strategy and operational plan for all projects associated with 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 overall Takeda global program portfolio. The Vice President, GPL role will lead projects with the highest complexity and highest risk for Takeda and will be responsible for leading program innovation and buy-up opportunities to maximize product value. This role will oversee 5-8 projects across all phases of development and commercialization including innovative early POM/POC in novel mechanisms with less-defined regulatory approval pathways. Program activities include planning towards milestones, defining clear go/no go decision points, creating buy-up/buy-down scenario plans, managing critical path activities, proactively identifying issues, resolving conflicts and communicating project-related issues to senior executive management. The GPL establishes long-range plans and goals for global programs to achieve the TA Strategy and provides leadership and vision for the global regulatory submissions and approvals to achieve successful commercialization and maximize value for new products. Assist with setting strategy for the Management & Operations office, provide mentoring to other GPLs to drive program innovation and strategy.
Strategic Planning and Execution
- Leads the Global Program in setting project/product strategies, goals, priorities and long-term plans and schedules. Aligns cross-functional, cross-divisional project goals with Takeda business needs and strategies.
- Responsible for strategic, process, and operational leadership to multiple GPTs and Takeda functions in the successful delivery of projects from discovery to commercialization. Will manage 5 8 projects for across all phases of development including innovative early POM/POC in novel mechanisms with less-defined regulatory pathways through large-scale Phase III/submission projects and global launch projects.
- Links Division sub-teams, such as the GDT, Global Marketing Team, Global CMC team, etc. to the GPT through Divisional leaders/project management functions to align activities and ensure transparency of all project/product-related activity
- Provides leadership and support to TA Leaders and Sub-leaders to set the vision and direction for the Therapeutic Area and prioritizes all aspects of projects within a global program.
- Reports on progress of projects, issues/plans, and critical path schedules to TA Unit and Takeda executive management through internal or external reviews of global programs or projects.
- Leads key business initiatives: Evaluates new opportunities (i.e.: in-licensing candidates, impact of change in market conditions or availability of new project data in disease areas where Takeda has little or no previous experience) 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.
Resource and Issue Management
- 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 tracking key performance indicators (KPIs), trending, learning, and improving decisions regarding program performance and continuance.
Matrix Team Management
- Provides matrix management, strategic and tactical leadership to GPT members who are responsible for leading the key deliverables or Divisional sub-teams within individual projects.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Advanced scientific degree (MD, or PhD, or PharmD)
- Minimum of 15 years experience in the pharmaceutical industry, with working knowledge of research and development or commercial operations
- Minimum 10 years experience with increasingly complex pharmaceutical projects in a multi-disciplinary, global environment including strategy development and execution
- Minimum of 8 years matrix team management in a global environment
- Broad business orientation is highly preferred
- Managed multiple NME global approvals
Knowledge and Skills:
- Experience with project leadership and management systems and methodology to support consistency across multiple projects
- Multi-faceted background with direct involvement or experience working with functions from multiple divisions: Research, Development, CMCC, 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 stressful and demanding environment with aggressive project timelines
- Project Management Professional certification from PMI desired
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time.
- Ability to lift and carry over 25 pounds.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 20-25% travel.
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