Takeda
biotech/pharma
AssociateDirector,Drug-DeviceCombinationDevelopmentLead(DDL)
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“Associate Director, Drug-Device Combination Development Lead (DDL) at Takeda. Skills: drug–device combination product development, cross-functional leadership, strategy development, risk management, external partner management. leading and coordinating drug–device combination product development activities for assigned assets across the product lifecycle. driving product-specific strategy development, feasibility assessment, development execution, qualification planning, and regulatory submissio”
What You'll Achieve.
deliver program outcomes; ensure compliant execution aligned with relevant quality systems, internal SOPs and regulatory frameworks for combination products across the lifecycle; drive timely decisions
Industry & Context.
risk-based decision making; risk-based technical recommendations; risk-based approaches to resolve complex technical challenges; evaluate multiple inputs, identify trade-offs, and drive timely decisions; Proactively monitors program risks and develops mitigation scenarios
What They're Looking For.
Must Have
10+ years of relevant experience in biotech/pharma, demonstrated experience in drug–device combination products and/or container closure/primary packaging development, knowledge and understanding of drug device combination product development and commercialization in the pharmaceutical industry, understanding of the relevant regulatory frameworks that govern drug-device combination products across the product lifecycle, Demonstrated experience leading cross-functional, matrix teams and managing multiple complex workstreams to deliver program outcomes, Experience managing external partners/suppliers and outsourced technical work packages, technical knowledge of drug–device combination development, including interfaces between device, formulation, fill/finish, and analytical strategies, Ability to translate program strategy into tangible deliverables, phase-appropriate plans, and risk-based recommendations, planning and program execution discipline (timelines, risks, dependencies, documentation readiness), Demonstrated ability to evaluate multiple inputs, identify trade-offs, and drive timely decisions, Fluent (spoken and written) in English
Nice to Have
MS/PhD preferred
What You'll Do.
leading and coordinating drug–device combination product development activities for assigned assets across the product lifecycle
driving product-specific strategy development
feasibility assessment
development execution
qualification planning
and regulatory submission readiness through lifecycle management
providing dedicated combination-product leadership
ensuring that device-related development plans and evidence packages are integrated into the overall CMC and product strategy
leading the device sub-team for combination products
developing and driving product-specific drug–device combination strategy across the lifecycle
defining and maintaining a phase-appropriate evidence plan for combination product development
contributing to asset-level integrated planning
providing risk-based technical recommendations and decision support
leading the device subteam for drug–device combination product development
leading and/or coordinating device qualification activities
leading and/or coordinating drug–device compatibility strategy and execution
ensuring compliant execution aligned with relevant quality systems
internal SOPs and regulatory frameworks
representing the device subteam on cross-functional program teams
and ensuring execution of integrated workplans/timelines for device-related activities
managing meeting cadence
contributing to establishing end-to-end capability for drug–device combination development
driving innovation for device solutions through technology scouting and evaluation
supporting adoption of model-informed approaches for combination products
establishing and maintaining collaborative relationships with external partners
supporting sourcing strategy and partner governance
supporting due diligence or business development assessments related to combination products
How You'll Work.
Team & Collaboration
cross-functional leadership; leading cross-functional, matrix teams; coordinating cross-functional inputs; representing the device subteam on cross-functional program teams; building alignment across functions and external partners; global/cross-cultural collaboration
Communication Scope
Clear, polished communication skills (written and oral) appropriate for governance and senior stakeholder engagement
Process & Methodology
integrated planning, phase-appropriate plans, integrated workplans/timelines, program execution discipline, managing multiple complex workstreams, managing external partners/suppliers and outsourced technical work packages, common program management tools
Full Job Description
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s [Privacy Notice](https://jobs.takeda.com/privacynotice) and [Terms of Use](https://www.takeda.com/terms-and-conditions/). I further attest that all information I submit in my employment application is true to the best of my knowledge. ## **Job Description** Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Drug-Device Combination Lead our Lexington, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health and a Brighter Future_** to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Director, Drug–Device Combination Development Lead (DDL) is responsible for leading and coordinating drug–device combination product development activities for assigned assets across the product lifecycle. This role leads the device sub-team for combination products (e.g., prefilled systems and associated primary packaging), driving product-specific strategy development, feasibility assessment, development execution, qualification planning, and regulatory submission readiness through lifecycle management (LCM). The DDL provides dedicated combination-product leadership and ensures that device-related development plans and evidence packages are integrated into the overal
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