US-MA, Lead, Advanced Drug Delivery Tech Dev SR0024479-MZ
Primary Duties Devices/delivery systems constitute the user interface for patients and customers using Takeda products, are key to the user experience. The Takeda Device Strategy and Technology Development (DSTD) group in Lexington, Massachusetts assesses drug delivery requirements for early-stage programs and life-cycle enhancements for on-market products, recommends potential device solutions, performs feasibility assessments and develops business cases to support device project team assignment, and leads technology transfer to Device Development team. Working closely with commercial, clinical development, device and drug product partners, the DSTD group is responsible for driving early stage device/delivery system initiatives to entry to development. Key activities include: Lead identification and assessment of new/emerging drug delivery technologies and partners with potential application to Takeda products; Plan and lead realization of novel drug delivery/device concepts through prototyping, feasibility demonstration ( proof of concept ) and transfer to Device Development; Lead cross-functional Product-Device Strategy sub-teams, and collaborate with key stakeholders (commercial, clinical development, device) to drive development of Target Device Profile (TDP) and business case development for project justification and approval by governing bodies; Collaborate with commercial and human factors partners in user research efforts to uncover unmet user needs; Participate and support clinical advisory board meetings to uncover clinical value proposition for delivery devices; Develop presentations to seek endorsement of strategy and funding for early stage device projects; Lead and collaborate on project planning and budgeting activities in support of successful tech transfer to product development group Lead and participate in strategy sessions to develop multi-generational device plans that meet delivery requirements for Takeda s drug products Be sought out by others as an expert in drug delivery and combination product integration; Provide device/drug-delivery support to business development due diligences; Monitor market and competitive intelligence for impact on device strategy; Identify development partners/suppliers and nurture relationships through contracting; Ensure work and team activities are aligned with all relevant quality, regulatory, HSE, GLP, and GMP requirements. Responsibilities Job Function and Description - % of Time 50% Identification and assessment of emerging drug delivery technologies 10% Supplier partnership development 15% Support to business development due diligence 25% Project business case and TDP development Education and Experience Requirements: Education: BS/BEng in relevant engineering or scientific area of study (typically, mechanical or biomedical engineering) with minimum ten (10) years experience in Medical Device development Or MS in relevant engineering or scientific area of study (typically, mechanical or biomedical engineering) with minimum eight (8) years experience in Medical Device development Experience in medical device development and application of Design Controls and Risk Management Preferred: Experience with combination products Demonstrated experience in performing technology assessments (typically supporting due diligence activities) Drug (small molecule and/or biologic) delivery experience Key Skills, Abilities, and Competencies: Has demonstrated expertise in medical device design and application of Design Controls and Risk Management; Has an understanding of system level considerations for drug delivery device development (primary drug packaging, filling, and drug compatibility); Is able to critically evaluate opportunities and assess risks; Is able to work collaboratively; Has excellent written and oral communication skills; is able to tailor communications for the audience; can communicate complex topics to a lay audience; Is able to think creatively and offer solutions that may not be obvious; Is able to influence decision-making; Understands how user needs drive requirements; Is able to estimate activities and resources required to support a project; Takes initiative and is able to progress activities with minimum of oversight. Complexity and Problem Solving: The incumbent will recommend potential technologies and potential development partners, and in conjunction with commercial, develop business cases to support project approval and entry to the next stage of development. The incumbent will work, under confidentiality, with business due diligence teams.
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