Provides global program management and matrixed leadership to global, cross-functional, cross-divisional teams to drive development and deliver results in 1) early to late-phase complex (i.e., multi-region/indications and/or alliance partners) major development 2) lifecycle management programs (including established/marketed products) 3) post-marketing commitments to meet Takeda s strategic objectives.
- Responsibilities include providing strategic direction and translating the cross-divisional, integrated Global Product Team (GPT) strategy into an efficiently executable plan; predicting and planning solutions to achieve program goals and objectives; driving clarity and removing barriers to ensure team success; interfacing with management, influencing decision-making, proactive management and mitigation of development risks, and ensuring appropriate communication and interface with internal governance.
- Works closely with the Global Program Leader (GPL) and other R&D & Commercial functions to ensure that scientific & commercial strategies are incorporated into the asset strategy and integrated development plan (IDP) for the TAUs and into the product strategy and an integrated operational plan for MPG.
- May lead key initiatives that have cross-functional or cross-divisional impact that are critical to the objectives of the Therapeutic Area Unit (TAU) or the Marketed Products Group (MPG), Center of Operational Performance (CoOP), CMSO and/or global business objectives.
- Play a key role in ensuring team effectiveness, partnering with GPL and CoOP to administer team health checks to generate insights, plan & execute appropriate follow-up actions.
- Identifies and drives innovative process improvements with significant organizational impact and manages, as needed, non-project responsibilities, which can include processes and system optimizations.
- May have direct people management responsibilities.
- Partners with GPL to lead GPT or joint Program Team (for partnered/alliance programs) and/or other cross-functional teams to develop/maintain asset/product strategy & IDP/operational plan (OP) aligned with TAU/MPG & commercial strategy, lifecycle management (LCM) requirements, and evidence generation/publication needs.
- Proactively identifies resource requirements necessary to progress asset development in alignment with TAU/MPG or enterprise business objectives.
- Drives clarity with GPT and other relevant stakeholders to communicate asset/product strategic imperatives to ensure appropriate prioritization.
- Identifies ways to optimize program execution without compromise to patients or compliance.
- Accountable to maintain the integrated program level plan, ensuring delivery of critical path activities to progress asset development.
- Partners with GPL to identify and drive asset/product development resource priorities that align with R&D and business/commercial strategies and goals.
Program Operational Excellence
- Ensures asset/product strategy & IDP/OP are aligned with GPT, have a patient-centric focus, & incorporate innovative approaches meaningful to patients, HCPs, regulators & payers, adhere to highest standards of operational excellence in drug development/regulatory compliance.
- Manages the strategic GPT forum and assigned sub-teams to ensure progress of asset development / continuous product registration and availability. This includes establishing meeting agendas, facilitating effective team discussions, driving to clear and timely team actions and decisions, driving and holding team members accountable for action item follow-through.
- Ensures team effectiveness through team health checks with development and appropriate follow-through on action plans to boost team productivity.
- Partners with the GPL to provide financial oversight of the program including global, cross-divisional budgets. Includes consolidation, vetting and prioritization of GPT spending to deliver critical path activities.
- Supports external vendor management and works closely with global CRO partner(s) for appropriate functional support.
- Proactively addresses and removes barriers to program progress, keeping leadership informed of critical considerations (e.g., resources, performance).
- Proactively identify potential issues or obstacles and achieves resolution or plans contingencies. Follow issues through to resolution ensuring that all key stakeholders are informed of outcomes and program implications.
- Provides clarity and direction in urgent or unexpected situations. Independently resolves complex issues & competing priorities that may impact goal achievement, creates mitigation plans and drives to resolution.
- Leads the GPT project risk management process in the team and generates the cross-functional, cross-divisional project risk register for assigned products.
Communication and Reporting
Manage scheduled/ad-hoc program reporting, citing program goals/KPIs status, proactively identifying risk & planned mitigation(s), provide rationale for timeline & budget variances.
- Participate in annual portfolio analyses to communicate program development progress, opportunities, and risks to Senior & Executive Management.
- Responsible for leading preparation efforts for governance engagement to support and drive asset objectives and deliverables.
- Proactively manages key stakeholders and facilitates or leads relevant communications to appropriate cross-regional, cross-functional, cross-divisional and Alliance partners
- Provides direction and mentors junior colleagues to work strategically and drive results; identifies opportunities for junior PMs to demonstrate their abilities; uses effective coaching techniques to refocus energy and address barriers to success; leads by example
- May have line management responsibility of Sr. Manager GPMs and contractors within GPM function.
- May support Business Development in-licensing activities to ensure appropriate technical assessment, including development costs and timelines, to support the business case of potential in-licensed compounds.
- May work as Alliance Manager for partnered programs under the guidance of the TAU Alliance Management team.
EDUCATION & EXPERIENCE/SKILLS:
- Bachelor s Degree science or business-related field
- Advanced degree in science or business is preferred
- Minimum of 8-10 years of strong pharmaceutical industry experience and drug development in all phases of development with significant experience within related functions (e.g. Clinical Science, Clinical Operations, Research, Regulatory, CMC, Marketing)
- Minimum of 5 years program management experience leading complex pharmaceutical projects in a multi-disciplinary, global environment
- Demonstrated ability to positively influence outcomes, key project decisions, and strategic problem-solving
- Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management
- Substantial experience in intercultural cooperation
- Modest people management experience and/or proven leadership experience in managing global, matrix teams
Knowledge and Skills
- Matrix program leadership and management skills are required
- Therapeutic Area knowledge preferable, but not required
- Strong influencing skills
- Ability to predict risks and independently propose solutions and appropriate mitigation plan
- Highly effective presentation, written and verbal communication skills
- Ability to drive decision-making within cross-functional & cross-cultural, global team structures
- Simultaneous management of multiple tasks of varied complexity
- Flexibility, tolerance and diplomacy to best manage change and differing opinions
- Ability to work in a virtual setting/across time-zones, i.e., making effective use of communication tools (WebEx, TelePresence, telephone and video conferencing, etc.)
- Ability to inspire and motivate in a matrix and global, cross-geographical team
- Ability to work in a highly complex, multi-cultural, environment
- Excellent organizational skills
- Experience with Microsoft Project Professional, Excel, PowerPoint & Word
- Fluent in English
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