Associate Director, Drug-Device Combination Development Lead; DDL

Position: Associate Director, Drug-Device Combination Development Lead (DDL)
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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 overall CMC and product strategy. The role requires strong cross-functional and external partner leadership, risk-based decision making, and the ability to translate program strategy into actionable plans and deliverables.

POSITION

ACCOUNTABILITIES :

Drug-device combination product strategy & integrated planning

* Develop and drive product-specific drug-device combination strategy across the lifecycle (feasibility through LCM) in alignment with overall program strategy.

* Define and maintain a phase-appropriate evidence plan for combination product development (including Target Device Profile (TDP) alignment to the Target Product Profile (TPP) where applicable).

* Contribute to asset-level integrated planning, including identification of key risks, dependencies, and contributions to business case assessments (e.g., complexity, timelines, resourcing/externalization needs).

* Provide risk-based technical recommendations and decision support for key trade-offs across device, drug product, and manufacturing interfaces

Device subteam leadership (development and qualification)

* Lead the device subteam for drug-device combination product development, coordinating cross-functional inputs (Device Engineering, Human Factors, Quality, Regulatory, Clinical/Medical, Procurement, Manufacturing/Tech Ops interfaces).

* Lead and/or coordinate device qualification activities appropriate to development stage (e.g., verification/validation planning, supplier qualification interfaces, documentation readiness).

* Lead and/or coordinate drug-device compatibility strategy and execution in collaboration with formulation/fill-finish and analytical partners, including relevant interfaces such as extractables/leachables, container closure integrity, functional performance, and stability linkages.

* Ensure compliant execution aligned with relevant quality systems, internal SOPs and regulatory frameworks for combination products across the lifecycle.

Cross-Functional Representation & Internal Stakeholder Management

* Represent the device subteam on cross-functional program teams to ensure alignment of combination product deliverables with program needs.

* Create, manage, and ensure execution of integrated workplans/timelines for device-related activities by building alignment across…