Shire Global Program Manager - Devices in Cambridge, Massachusetts

The Global Program Manager Devices (GPMD) is responsible for managing the operational planning, execution, and decision-making processes for development and commercialization phases of less complex Device Teams (DT) for devices and driving activities and being a team member in more complex DTs at Shire. The GPMD works closely with the Device Program Lead (DPL) and the Device Clinical Lead (DCL). The GPMD also works to ensure the cross-functional teams operate effectively with positive Global team dynamics. For combination products the GPMD is expected to work closely with his/her GPM Drug counterpart to ensure full alignment.

As a key member of DT, the GPMD is expected to be knowledgeable about the overall device development program (i.e., Design Controls, Change Control, Device Regulations, etc…) in order to be strategic in planning, team management and process management. The GPMD achieves this by delivering high quality program management support and other high value services that supports the team and improves the probability of program success.

The GPMD will be responsible for actively working with the DPL and DCL to manage the operational, planning and decision-making aspects of the DT (generally, less complex programs) to ensure strong alignment between product strategy and operational execution.

Responsibilities:

80%

The GPMD works closely with DT/EPT/LPT members to ensure timely completion of deliverables required to ensure robust and balanced cross-functional planning, decision-making, implementation and monitoring of global programs:

  • Working closely with their manager but with minimal direct routine supervision responsible for providing best in class operations and program management.

  • Works with DPL/DCL/GDL/PSL to facilitate the elaboration, approval and execution of the global 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 the program strategy.

  • Maintain the overall SPP in collaboration with the program team members.

  • Collaborate with DPL, DCP, GDL, 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.

  • Work independently to provide best-in-class operations and program management expertise to drive DT/GPT 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

10%

The GPMD contributes to the development and execution of cross-business initiatives and processes.

0-10%

Managing processes of defined scope required for effective program management (if appropriate)

Education and Experience

  • Minimum of 5-7 years of experience in device development in a pharmaceutical environment and/or Minimum of 3 years of cross-functional program management experience in managing a diversity of device projects and multiple stages of development and commercialization of the device.

  • Demonstrated ability to manage complex cross-functional teams and processes and work without routine supervision to deliver key accountabilities.

  • Strong understanding of the business environment and relevant key strategic and operational drivers.

  • Working knowledge of elements of device related product development:

  • Design Controls (DIs/DOs)

  • Translation of User Needs to Product Requirements

  • Change Control and Design Transfer

  • Verification & Validation (V&V)

  • Forwards/Backwards Traceability

  • 21CFR820

  • DFMEA/6σ/DMAIC

  • Exposure with subcontractor management and CMOs.

  • Project Management Professional (PMP) certification or equivalent proficiency a plus.

  • Knowledge and understanding of global device development and commercialization in the pharmaceutical industry.

  • 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.

  • BS in engineering discipline, or MBA with relevant industry experience.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire 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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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.