Associate Director, Drug-Device Combination Development Lead (DDL)
Takeda
June 24, 2026
Remote friendly (Lexington, MA)
United States
$154,400 - $242,550 USD yearly
Clinical Research and Development
POSITION OBJECTIVES
The Associate Director, Drug–Device Combination Development Lead (DDL) leads and coordinates drug–device combination product development activities across the product lifecycle, driving device sub-team strategy, feasibility assessment, development execution, qualification planning, and regulatory submission readiness.
POSITION ACCOUNTABILITIES
- Develop and drive product-specific drug–device combination strategy across the lifecycle (feasibility through lifecycle management), aligned to program strategy.
- Define/maintain phase-appropriate evidence plans (including TDP-to-TPP alignment where applicable).
- Support integrated planning: risks, dependencies, and inputs to business case assessments.
- Provide risk-based technical recommendations for trade-offs across device, drug product, and manufacturing interfaces.
- Lead device sub-team: coordinate cross-functional inputs (Device Engineering, Human Factors, Quality, Regulatory, Clinical/Medical, Procurement, Manufacturing/Tech Ops).
- Lead/coordinate device qualification and documentation readiness.
- Lead/coordinate drug–device compatibility strategy (e.g., extractables/leachables, container closure integrity, functional performance, stability linkages).
- Ensure compliant execution aligned with quality systems/SOPs/regulatory frameworks.
- Represent device sub-team on program teams; manage integrated workplans/timelines, decision logs, and risk registers.
- Build combination-product capability; drive innovation via technology scouting.
- Lead external partner/supplier relationships (vendors/OEMs/testing labs/CMOs); support sourcing governance and technical due diligence.
EDUCATION & EXPERIENCE
- Required: BS/BEng in engineering/pharmaceutical sciences/materials science or related.
- Preferred: MS/PhD.
- Required: 10+ years biotech/pharma experience with drug–device combination and/or container closure/primary packaging development.
KEY SKILLS
- Strong drug–device combination technical knowledge and interface expertise (device, formulation, fill/finish, analytical).
- Risk-based, decision-oriented leadership; ability to translate strategy into deliverables.
- Strong communication, planning, stakeholder management, and cross-functional collaboration.
- Familiarity with integrated plans/risk registers; proficient in Microsoft tools. Fluent English.
Benefits / Compensation (as stated)
- Hybrid role; Lexington, MA. U.S. base salary range: $154,400–$242,550. Eligible for incentives and benefits (medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being), plus up to 80 hours sick time and up to 120 hours paid vacation for new hires.
APPLICATION INSTRUCTIONS
- No phone calls or recruiters please.
The Associate Director, Drug–Device Combination Development Lead (DDL) leads and coordinates drug–device combination product development activities across the product lifecycle, driving device sub-team strategy, feasibility assessment, development execution, qualification planning, and regulatory submission readiness.
POSITION ACCOUNTABILITIES
- Develop and drive product-specific drug–device combination strategy across the lifecycle (feasibility through lifecycle management), aligned to program strategy.
- Define/maintain phase-appropriate evidence plans (including TDP-to-TPP alignment where applicable).
- Support integrated planning: risks, dependencies, and inputs to business case assessments.
- Provide risk-based technical recommendations for trade-offs across device, drug product, and manufacturing interfaces.
- Lead device sub-team: coordinate cross-functional inputs (Device Engineering, Human Factors, Quality, Regulatory, Clinical/Medical, Procurement, Manufacturing/Tech Ops).
- Lead/coordinate device qualification and documentation readiness.
- Lead/coordinate drug–device compatibility strategy (e.g., extractables/leachables, container closure integrity, functional performance, stability linkages).
- Ensure compliant execution aligned with quality systems/SOPs/regulatory frameworks.
- Represent device sub-team on program teams; manage integrated workplans/timelines, decision logs, and risk registers.
- Build combination-product capability; drive innovation via technology scouting.
- Lead external partner/supplier relationships (vendors/OEMs/testing labs/CMOs); support sourcing governance and technical due diligence.
EDUCATION & EXPERIENCE
- Required: BS/BEng in engineering/pharmaceutical sciences/materials science or related.
- Preferred: MS/PhD.
- Required: 10+ years biotech/pharma experience with drug–device combination and/or container closure/primary packaging development.
KEY SKILLS
- Strong drug–device combination technical knowledge and interface expertise (device, formulation, fill/finish, analytical).
- Risk-based, decision-oriented leadership; ability to translate strategy into deliverables.
- Strong communication, planning, stakeholder management, and cross-functional collaboration.
- Familiarity with integrated plans/risk registers; proficient in Microsoft tools. Fluent English.
Benefits / Compensation (as stated)
- Hybrid role; Lexington, MA. U.S. base salary range: $154,400–$242,550. Eligible for incentives and benefits (medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being), plus up to 80 hours sick time and up to 120 hours paid vacation for new hires.
APPLICATION INSTRUCTIONS
- No phone calls or recruiters please.