Director, Global Program Management Lead (Software Medical Devices)position is a high impact, leadership role responsible for key elements of program strategy, planning and cross-functional execution of the development and commercialization activities for devices within the Device Center of Excellence. The Device GPM role requires a talented individual with proven expertise in leading cross-functional team activities and driving product strategy, planning and program execution. The Device GPM, in partnership with the Device Development Lead (DDL) will drive program management ensuring the translation of product strategy into clear and actionable plans/deliverables. The Device GPM works closely with Regulatory Affairs and Device Quality to address Regulatory and Compliance requirements for software medical devices that are launched globally. The Device GPM will also work closely with the GPL on the GPT as appropriate to ensure Device/Drug strategies/projects align and provide timely reporting to Sr Management.
As a Lead of the Device Sub-Team (DT), the Device GPM is expected to be knowledgeable about the overall device program (i.e., Design Controls, Change Control, Device Regulations, etc ) in order to be strategic in planning, program progress oversight/execution, communication and process management. The Device GPM achieves this by delivering high quality program management and other high value services that support the team and improve the probability of program success.
The Device GPM will be responsible for one or more programs with clearly defined objectives.
80%: Device Strategy / Operations / Program Management
- Work closely with the DDL to facilitate the elaboration, approval and execution of the global device program strategy.
- Coordinate and drive operational planning activities of the GPT including Strategic Product Plans (SPP), Target Device Profile (TDP), TPP alignment, Long Range Plan, Life Cycle Management Plan, Geographical Expansion Plan, Business Cases, Competitive Landscape assessment and IP assessment ensuring alignment to program strategy.
- Maintain the overall SPP in collaboration with the program team members.
- Collaborate with DDL, GPL, PSL and DT functional team members to ensure coordinated evaluation of product opportunities/ scenarios and development of comprehensive integrated recommendations (e.g., to Governance Committees) and strategic and operational product plans based on program defined objectives and priorities.
- Drive program execution excellence and assure alignment with GPL, PSL and product GPM.
- Work independently to provide best-in-class operations and program management expertise to drive DT members towards excellence in execution of plans:
- Develop, maintain and track robust, cross-functionally aligned program timelines (development and launches)
- Facilitate collection, alignment and validation of program budget ensuring alignment to program strategy
- Lead and facilitate cross-functional team meetings (agendas, minutes, tracking actions, etc.)
- Facilitate team goal setting and tracking to ensure adherence to plan and strategy, and end of year team evaluation process
- Develop and manage a program risk register
- Coordinate DT communications to ensure team member alignment
- Issue and present reports to senior management on a routine basis
- Facilitate preparations and analyses of DT business reviews and routine evaluation processes, and progress against DT strategy and action plans.
- Serve as strong objective advisor to DDL to maximize team effectiveness.
- Promote visibility and transparency of information within the DT, across DT sub-teams and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge, identify and communicate product and DT related objectives, issues, risks, and where applicable, facilitate cross-DT discussion on impact.
- Provide clear direction on product development approaches and requirements to meet expectations of external customers and business stakeholders.
- Collaborate with Regulatory Affairs and Device Quality to insure Regulatory and Compliance requirements for software medical devices are addressed across all geographies.
- Be responsible for making decisions regarding the appropriate risk when there is substantial program impact.
- Reinforce product governance and team operating principles to maximize alignment within the team and with other functions.
20%: R&D Program Management Processes and R&D Initiatives
- Active participation in the GPM team and PM forums to deliver GPM initiatives and build a center of program and project management excellence.
- Support TAU and R&D initiatives as required.
Education and Experience Requirements
- Minimum of 10-12 years of experience in device development in a pharmaceutical environment
- Minimum of 6 years of cross-functional program management experience in managing a diversity of device projects and multiple stages of development including commercialization and global launch of the device.
- Demonstrated ability to manage complex cross-functional teams and processes
- Strong understanding of the business environment and relevant key strategic and operational drivers.
- Strong understanding and demonstrated experience with software medical device related product development:
- Translation of User Needs to Product Requirements
- Design Controls (DIs/DOs)
- Change Control and Design Transfer
- Verification & Validation (V&V)
- Human Factors and UX Design
- 21CFR820, ISO 13485, MDSAP and MDR
- Software development lifecycle and lifecycle management
- Software globalization and localization
- Demonstrated experience with device regulatory submissions on a global basis
- Very good knowledge end execution of subcontractor management and CMOs.
- Demonstrated ability to work without routine supervision to deliver key accountabilities.
- Strong understanding and competency in planning processes and decision making
- Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring.
- Training, coaching and leadership experience.
- Project Management Professional (PMP) certification or equivalent proficiency a plus.
- Demonstrated finance and business acumen.
- Bachelor s degree in engineering; advanced degree in life sciences or MBA preferred.
Other Job Requirements
International and domestic travel as required
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