The Device Program Leader (DPL) position is a high impact leadership role responsible for leading device development program strategy and cross-functional execution of development and commercialization activities within the Device Team (DT). The DPL role requires a talented leader with proven expertise in overseeing cross-functional team activities and driving device product strategy planning and program execution. As a key member of the device team, The DPL will drive device program execution ensuring the translation of product strategy into clear and actionable plans/deliverables. The DPL will also work closely with the GDL/PSL on the EPL/LPT/TOPT as appropriate to ensure Device/Drug strategies/projects align.
As the leader of the more complex DT, the DPL is expected to be knowledgeable about the overall device development program (i.e., Design Control, Change Control, Device Regulations, etc.) in order to be strategic in planning, program progress oversight/execution, communication, and process management. The DPL achieves this by delivering high quality program leadership and other high value services that support the team and improve the probability of program success.
Responsibilities (% of time):
- The DPL facilitates elaboration, approval, and execution of the global device program strategy
- Lead ExCo priority device program and explore program acceleration and risk mitigation
- Lead and drive operational planning activities of the DT including Strategic Device Plans, Target Device Profile (TDP), TPP alignment, Long Range Plan, Life Cycle Management Plan, and Geographical Expansion Plan, ensuring alignment to program strategy.
- Maintain the overall SPP in collaboration with the program team members.
- Collaborate with DCL, GDL, PSL, DT and TOPT 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 GDL, PSL and product GPM.
- Develop, maintain and track robust, cross functionally aligned program timelines
- Facilitate collection, alignment and validation of program budget ensuring alignment to program strategy
- Facilitate preparations and analyses of DT business reviews and routine evaluation processes, and progress against DT strategy and action plans.
- 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 requirements in alignment with the Product/Device operating model to meet expectations of external customers and business stakeholders.
- Demonstrate strong finance and business acumen and oversight of the device program budget and long range plan.
- Expertise in design controls, biocompatibility, sterilization validation, packaging validation, and shelf life stability programs
- Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and the Brand Teams.
- Establishing and fostering strong collaborative relationships with external design/development, manufacturing partners and service providers.
- Works closely with the procurement team on contract vendor selection, outsourcing models, and vendor evaluation audits, for medical device partners and combination products.
- Recruit and manage external resources, such as, Consultants and Contractors, as needed to deliver projects.
- To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations.
- Represents device development and external manufacturing on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions.
- Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.
- Bachelor’s degree in Engineering or related field required with a minimum of 12 years of experience in device development and commercialization with demonstrated success leading multi-site, global or enterprise-wide programs in the biotech/pharmaceutical industry. (MS desired, MBA or relevant industry experience preferred.
- Knowledgeable in at least one functional area (proven experience) in the development of a pharmaceutical device; must be able to assess validity of overall program/project strategy and deliverables.
- Proven Leader with ability to manage multiple complex cross-functional teams and processes to deliver key accountabilities.
- Demonstrated experience managing programs in different stages of development in diversity of therapeutic areas.
- Strong knowledge and understanding of global device product development and commercialization in the pharmaceutical industry.
- Strong understanding of the business environment and relevant key strategic, operational drivers and competitive environment.
- Excellent knowledge and application of elements of device related product development:
- Excellent knowledge and execution of subcontractor management and CMOs.
- 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.
Location/Region: Lexington, MA