Senior Director, Device Development
About The Position
About This Role: As the Senior Director of Device Development, you will lead the charge in selecting, developing, and managing the lifecycle of platform and innovative non-implantable drug delivery devices, focusing on prefilled syringes, autoinjectors, and on-body delivery systems and combination product development. Joining the Product Delivery Solutions team, your role is crucial in advancing technology from conception through commercialization, ensuring these solutions enhance patient experiences and clinical performance. You will shape the combination product device portfolio strategy, influencing enterprise investment decisions and positioning Biogen competitively in the subcutaneous and home-use landscape. Reporting to this role is a multidisciplinary engineering organization, which you will oversee to drive iterative design, risk reduction, and scalability through prototyping. Collaborating alongside leaders in Implantable Device Technologies and Regulatory, you will guide cross-functional delivery architecture and portfolio decisions. Your focus will be on championing patient-centric delivery innovation while maintaining operational rigor and regulatory readiness. This role also emphasizes talent development and strives to enhance Biogen's influence in combination product development. What You’ll Do: Lead strategic direction for combination product development to ensure alignment with business objectives. Influence portfolio decisions related to device strategy, presentation, and route of administration. Oversee an internal prototyping laboratory to accelerate design iterations and platform scalability. Drive model-informed development practices for robust, data-driven decision-making. Develop talents across a multidisciplinary engineering organization. Enhance Biogen’s external recognition in combination product development through strong leadership. Inform and approve regulatory strategies and represent Biogen in meetings with regulatory agencies. Liaise with external partners to develop strategic relationships and enhance Biogen's voice in industry forums. Who You Are: You are a visionary leader with a deep understanding of combination product device development and the subcutaneous device landscape. Your strong communication and collaboration skills enable you to connect with all levels of the organization. You thrive in a matrix environment, embracing change and leading teams through dynamic challenges. Your ability to anticipate business needs and develop strategic medical device plans across the organization sets you apart. You are committed to championing patient-centric innovation while fostering an inclusive and growth-oriented culture.
Requirements
- BS degree in Engineering with a minimum of 15 years of relevant experience. Commensurate education and experience may also be considered.
- Extensive experience in drug-device combination product development within the medical device or pharmaceutical industry.
- Strong knowledge of regulatory and compliance requirements for device design controls and combination products.
- Excellent communication, collaboration, and team-building skills.
- Ability to lead teams through uncertainty and dynamic environments.
- Deep understanding of manufacturing processes for assembly of medical devices.
- Established external network across platforms, developers, CDMOs, suppliers, and key opinion leaders.
Responsibilities
- Lead strategic direction for combination product development to ensure alignment with business objectives.
- Influence portfolio decisions related to device strategy, presentation, and route of administration.
- Oversee an internal prototyping laboratory to accelerate design iterations and platform scalability.
- Drive model-informed development practices for robust, data-driven decision-making.
- Develop talents across a multidisciplinary engineering organization.
- Enhance Biogen’s external recognition in combination product development through strong leadership.
- Inform and approve regulatory strategies and represent Biogen in meetings with regulatory agencies.
- Liaise with external partners to develop strategic relationships and enhance Biogen's voice in industry forums.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Director
