Provides global program management and matrixed leadership to global, cross-functional, cross-divisional teams to drive development and deliver results in early to late-phase complex (i.e., multi-region/indications and/or alliance partners) major development or lifecyle management programs (including established/marketed products) 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).
- May lead key initiatives that have cross-functional or cross-divisional impact that are critical to the objectives of the Therapeutic Area Unit (TAU), 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 lead key initiatives that have critical cross-functional or -divisional impact related to TAU, R&D-wide, or global business objectives.
- May have direct people management responsibilities.
- Partners with GPL to lead GPT or joint Program Team (for partnered programs) and/or other cross-functional teams to develop/maintain asset strategy & IDP aligned with TAU & commercial strategy, lifecycle management (LCM) requirements, and evidence generation/publication needs.
- Proactively identifies resource requirements necessary to progress asset development in alignment with TAU or enterprise business objectives.
- Drives clarity with GPT and other relevant stakeholders to communicate asset 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.
Program Operational Excellence
- Ensures asset strategy & IDP 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.
- Manages the strategic GPT forum and assigned subteams to ensure progress of asset development. 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 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.
- 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.
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 and/or Associate Director level GPMs and contractors within GPM function.
- May act as delegate to GPM Head.
- 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, BEHAVIORAL COMPETENCIES AND SKILLS
- Minimum of a Bachelor s Degree in a science or business-related field
- Advanced degree in science or business is preferred
- Minimum 15 years of detailed & in-depth 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 8 years program management experience leading complex pharmaceutical projects in a multi-disciplinary, global environment
- Demonstrated ability to positively influence outcomes, key project decisions, & strategic problem-solving
- Proven ability to communicate clearly & present key information objectively to all levels of the organization including executive management
- Substantial experience in intercultural cooperation
- Proven people management experience and in leading global, matrix teams
Knowledge and Skills
- Matrix program leadership and management skills are required
- Thorough knowledge of Therapeutic Area preferable but not required
- Strong influencing skills and ability to negotiate in a matrix environment to optimize development and address barriers
- Proactively identify 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
- A solid business background including an excellent commercial understanding
- Experience with Microsoft Project Professional, SharePoint, Excel, PowerPoint & Word
- Fluent in English
- May travel to the US, EU and Japan offices and other international locations.
- Approximately 10% travel is required.
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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