The Global Device Program Manager (GDPM) is a core member of the cross-functional Device Team (DT) at Takeda. As the team s operational manager, the GDPM will work closely with DT s team leader, the Device Development Lead (DDL), to ensure the team is operating effectively and efficiently with positive team dynamics. The GDPM s primary role is to support the Device DDL and the other members of the DT by managing the day-to-day planning, execution and monitoring of device and combination product development efforts through the application of standard project management methods, tools and techniques.
The GDPM will collaborate with the DDL to ensure a strong alignment between overall product strategy and the operational plans of the DT. Specifically, the GDPM is responsible for building and updating integrated project schedules and budgets, for tracking variances vs. plan (including schedule, budget and resources), and for establishing and supporting mechanisms (team meeting cadence, project governance, team repositories, project reporting, etc.) to increase team effectiveness, improve stakeholder management and increase probability of program success. The GDPM will facilitate proactive risk management and contingency planning, issue management and decision-making processes for the team. For combination products, the GDPM is also expected to work closely with his/her CMC PM counterpart to ensure interdependencies between device and CMC are properly accounted for and integrated into each team s operational plans.
Job Function and Description
75% of Time
- Support the DDL in establishing device and combination product milestones, goals and KPIs in alignment with the overall program goals and objectives.
- Lead and facilitate operational planning activities for the DT to develop detailed, integrated project schedules for device work streams to support day-to-day execution.
- Manage and maintain the integrated project schedule by tracking the DT s activities on a regular basis. Work closely with the team to manage the critical path and ensure that any variances are escalated promptly to the DDL.
- Support Takeda s budget forecasting processes by working with DT members to develop short and long-term budget forecasts in alignment with project schedules and within the budgetary constraints of the program. Ensure budget forecasts are communicated appropriately to Finance and to key program stakeholders for transparency.
- Track actual project spend against approved budgets on a regular basis and support reporting of significant variances to the DDL, the Device CoE Leadership Team and to Finance.
- Collaborate with the DDL to prepare agendas for core team meetings and other project-related meetings, as appropriate. Prepare meeting minutes for the core team meeting and ensure action items and key decisions are captured and tracked.
- Lead proactive project risk planning for the DT. Working with the team, prepare and maintain a program Risk Register and facilitate risk and contingency planning to increase the program s probability of success.
- Assist DDL in communication within and outside of the DT to promote visibility and transparency of information, accelerate decision making, obtain alignment and increase foundational knowledge
- Assist DDL in the preparation for monthly Medical Device Program Review (MDPR), GPT updates and presentations to program stakeholders, as needed.
- Support DDLs and the broader DT in preparing for device stage gate reviews and design reviews.
- Work with DDL to establish decision-making processes and criteria, e.g. go/no-go criteria and stage-gate decisions.
- Reinforce team operating principles to maximize alignment within the team and with other functions.
- Establish and maintain a project document repository for the DT (e.g. SharePoint) to ensure that key program-related information is readily available to all team members and project stakeholders.
- Collaborate closely with CMC PM to facilitate the continued alignment of key information (i.e. schedules, budgets, risks, issues and decisions) across teams.
15% of Time
- Contribute to the continuous improvement of the Device Center of Excellence by supporting the development and deployment of new business initiatives, processes and best practices.
- Lead and facilitate schedule reviews with external partners and ensure that vendor s schedules are properly integrated into the DT s plans.
10% of Time
- Support recruitment and management of external resources, such as, Consultants and Contractors, as needed, to help deliver on project commitments.
- Remain current with innovations in the project management discipline through active engagement in professional organizations, ongoing training and maintaining professional certifications.
- Mentorship of more junior GDPM staff (if applicable).
Education & Experience Requirements
- Minimum of 5 years of direct, cross-functional project management experience within the medical device or pharmaceutical industry. Project management experience from other related industries will be considered.
- Minimum of 7-10 years of experience in medical device and/or combination product development experience, preferably in a pharmaceutical environment.
- Experience managing multiple programs, priorities, cross-functional teams and processes.
- Deep knowledge of and experience applying standard project/program management tools and techniques (below) to device development projects:
- Integrated project schedule planning and management, including critical path analysis
- Project budget planning, management and variance analysis
- Project risk and issue management, mitigation and scenario planning
- Scope management
- Resource estimation and planning
- Decision and action tracking
- Communication and reporting
- Meeting facilitation
- Knowledge and understanding of global device development and commercialization in the pharmaceutical industry.
- Working knowledge of FDA Design Controls (21 CFR 820) and other applicable global medical device and combination product regulations is strongly preferred.
- Financial and business acumen with an understanding of the business environment and relevant key strategic and operational drivers.
- Experience interfacing with or managing vendors, subcontractors, CMOs and other external partners.
- Experience using Microsoft Project and other Microsoft Office software including Excel, PowerPoint and Word, is required. Experience using and maintaining online collaboration sites, such as SharePoint, is strongly preferred.
- Project Management Professional (PMP) certification or equivalent proficiency a plus.
- BS degree required, preferably in an engineering discipline or equivalent, or MBA with relevant industry experience.
Key Skills, Abilities, and Competencies
- Strong competency in identifying and applying appropriate project/program management tools and techniques to facilitate the efficient initiation, planning, execution and monitoring of a project and project team.
- Ability to translate strategies into operational plans and tangible deliverables for team execution.
- Ability to manage multiple priorities and projects of varying complexity.
- Competency in basic finance, accounting and budgeting principles.
- Proactive self-starter who can work independently with minimal routine supervision.
- Strong interpersonal and soft skills including: meeting facilitation, cultural awareness and sensitivity, ability to use diplomacy and tact to facilitate effective conflict resolution within the team, and negotiation skills to facilitate efficient team decision making and alignment.
- Significant competency in operational management of cross-functional teams. Ability to operate and motivate a team in a completely matrix environment.
- Strong analytical skills to help facilitate effective problem solving and scenario planning.
- Detail-oriented with strong organization and documentation skills to ensure key decisions are captured and action items are tracked.
- Polished communication and presentation skills.
- In-depth knowledge and expertise in the use of Microsoft Project or other relevant project planning and management software.
- Ability to identify key priorities and help team members prioritize work.
- Ability to adapt quickly and effectively to changes to the program, the organization and culture.
- Training, coaching and mentoring skills.
- Fluency (spoken and written) in English.
Complexity and Problem Solving
- Guiding the cross-functional device team through program planning and execution, and leading the team through risk and issue management and resolution, is inherently complex.
- Requires a high level of problem-solving capability and ability to balance competing priorities and quickly and objectively drive the team toward a path that maximizes value.
Internal and External Contacts
Interacts regularly with the following internal contacts:
- Device Development Lead (leads the Device Subteam)
- Device Subteam cross-functional members (Engineering, Regulatory, Quality, Clinical, etc.)
- CMC Project Managers and CMC Teams
- Members of other non-Device functions/groups within Takeda
May also interact with personnel at external partners, including design/development partners, consultants, suppliers and CMOs.
Other Job Requirements
Domestic and international travel as required (up to 10%)
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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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