Associate Director, Drug-Device Combination Development Lead (DDL)

Takeda•Lexington, MA

3d•$154,400 - $242,550•Hybrid

About The Position

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.

Requirements

BS/BEng in engineering, pharmaceutical sciences, materials science, or related discipline required; MS/PhD preferred.
10+ years of relevant experience in biotech/pharma, with demonstrated experience in drug–device combination products and/or container closure/primary packaging development.
Strong knowledge and understanding of drug device combination product development and commercialization in the pharmaceutical industry.
Strong 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.
Strong 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.
Strong interpersonal skills (influencing without authority, negotiation, conflict resolution, global/cross-cultural collaboration).
Clear, polished communication skills (written and oral) appropriate for governance and senior stakeholder engagement.
Strong planning and program execution discipline (timelines, risks, dependencies, documentation readiness).
Demonstrated ability to evaluate multiple inputs, identify trade-offs, and drive timely decisions.
Familiarity with common program management tools (e.g., integrated plans, risk registers); proficiency in Microsoft tools.
Fluent (spoken and written) in English.

Responsibilities

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.
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.
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 functions and external partners.
Manage meeting cadence, decision logs, and risk registers for device subteam scope; escalate strategically when needed.
Contribute to establishing end-to-end capability for drug–device combination development within Drug product development (e.g., playbooks, templates, best practices, knowledge sharing).
Drive innovation for device solutions through technology scouting and evaluation, identifying opportunities to improve patient experience, manufacturability, robustness, and lifecycle flexibility.
Support adoption of model-informed approaches for combination products as an enabling development capability.
Establish and maintain strong collaborative relationships with external partners (vendors, OEMs, testing labs, CMOs) to enable execution of qualification, development, and submission-supporting activities.
Support sourcing strategy and partner governance to ensure quality, timeliness, and cost-effective execution.
Support due diligence or business development assessments related to combination products as needed (within scope of technical expertise).