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.
The GDPM is expected to work independently or with minimal supervision, and will be required to support multiple projects within the Device Center of Excellence (CoE).
80% 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.
5% 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.
Education & Experience Requirements
- Minimum of 3 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 5-7 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.
Other Job Requirements
Domestic and international travel as required (up to 10%)
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