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

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 functions and external partners.
• Manage meeting cadence, decision logs, and risk registers for device subteam scope; escalate strategically when needed.

Capability Building & Innovation Enablement

• 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

External Partner / Supplier Leadership

• 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)

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Education and Experience 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

Key Skills, Abilities, and Competencies

• 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.

Complexity and Problem Solving

• Leads combination product device subteam execution on one or more programs in parallel, with moderate-to-high technical complexity.
• Proactively monitors program risks and develops mitigation scenarios without compromising scientific rigor or compliance expectations.
• Applies risk-management based approaches to resolve complex technical challenges across device/drug/product interfaces.
• Escalates key strategic or portfolio-impacting issues appropriately with clear options and recommendations.

This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$154,400.00 - $242,550.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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