Senior Director, Device Development- Product Delivery Solutions
Biogen
12 hours ago
Remote friendly (Cambridge, MA)
United States
Operations
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.
Who You Are
- Seasoned leader with deep technical understanding of subcutaneous devices and combination product development; strong regulatory/compliance knowledge.
Required Skills
- 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.
Benefits (selected)
- 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).
Role Information
- Hybrid; based at Headquarters in Cambridge, MA.
- Job Level: Management.
- Base compensation range: $225,000–$310,000.
- 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.
Who You Are
- Seasoned leader with deep technical understanding of subcutaneous devices and combination product development; strong regulatory/compliance knowledge.
Required Skills
- 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.
Benefits (selected)
- 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).
Role Information
- Hybrid; based at Headquarters in Cambridge, MA.
- Job Level: Management.
- Base compensation range: $225,000–$310,000.