Senior Director, Device Development- Product Delivery Solutions

What You’ll Do

• Define and execute the end-to-end strategy for drug-device combination product development (concept through clinical, commercial, and lifecycle management).
• Translate early molecule needs into device roadmaps and delivery strategies, emphasizing subcutaneous delivery.
• Own technical execution of the design control process; lead prototyping, verification, and validation.
• Lead root cause investigations, deviations, and CAPAs.
• Solve complex drug-device integration and delivery performance challenges to ensure robust performance, reliability, and manufacturability.
• Drive system-level architecture and interface definition via integration of drug product and device components.
• Lead and develop multidisciplinary engineering teams as device subject matter experts (external to device manufacturing; internal to combination product development).
• Identify and mitigate technical, regulatory, and supply risks using design/process risk controls and risk management.
• Manage prototyping and device development laboratories to accelerate design and risk reduction.
• Drive data-driven decisions using model-informed development practices.
• Inform regulatory strategies and participate in regulatory meetings as needed.
• Develop strategic relationships; represent the organization in external industry forums.
• Ensure planning and milestone alignment across development programs.

• Seasoned leader with deep technical understanding of subcutaneous devices and combination product development; strong regulatory/compliance knowledge.

• Bachelor’s in Engineering with 15+ years relevant experience (or MS+12 years; or PhD+8 years).
• Extensive drug-device combination product development experience (medical device and pharmaceutical industry).
• Ability to lead/influence across matrixed organizations.
• Deep understanding of root cause investigations, human factors, regulatory requirements, and device design controls.
• Proven track record managing complex technical projects and strategic device solutions.
• Experience with model-informed development and digital twin simulation.
• Established external network in subcutaneous drug delivery device ecosystem.
• Strong communication and team-building skills.

• Medical, Dental, Vision & Life insurances; fitness & wellness reimbursement; short-/long-term disability; paid vacation and paid holidays; sick time; paid maternity and parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year).

• Hybrid; based at Headquarters in Cambridge, MA.
• Job Level: Management.
• Base compensation range: $225,000–$310,000.