Director of Device Strategy and Early Programs
- Full-time
- Region : US
- Department : Technical Development
About This Role
Do you have the skills to fill this role Read the complete details below, and make your application today.
The strategic vision of Biogen’s Global Reg CMC-Device, Packaging and Device Development organization is to lead the industry in user-centric drug-device combination product therapies.
We develop drug-delivery systems that are targeted, innovative, environmentally sustainable, and enhance the value of the therapy to the patient and health care system, in order to help patients improve their quality of life and empower them to take control of their disease.
Our mission is to support the Biogen R&D and commercial portfolio by delivering differentiated technology solutions that support administration of medicines to help patients, health care workers, care givers, and payers address unmet needs and provide improved health outcomes.
What You Will Do
As the Director of Device Strategy & Early Programs, you will lead our efforts to develop state-of-the-art drug delivery systems.
You will lead the collection of inputs and the assessment of innovative drug delivery and device technologies through both internal platform building and external partnerships.
You will engage with highly skilled engineers, scientists, and business leaders in the end-to-end development, industrialization, and life cycle management of medical devices.
- Partner with the VP of Device Pillar, Pharma and Biologics Pillars to implement current device product strategies and life cycle management, including forecasting for study costs and proposals for capacity and resource planning.
- Develop and maintain a strong network and partnership with R&D, Medical, Quality, Regulatory, Commercial, and across PO&T to ensure strong stakeholder ties and management.
- Facilitate gathering of cross-company inputs to guide and refresh device strategy roadmaps.
- Stay abreast of the technology and Regulatory landscape applicable to the global target markets of Biogen’s drug-device portfolio.
- Lead the generation and publication of patient preference and health economic evidence to support investment decisions.
Who You Are
You have a track record of fostering innovation and solving complex technical challenges in medical device development along with a strong understanding of combination product and medical device regulations and standards.
Required Skills
- BS in engineering or scientific discipline, advanced degree desired.
- Minimum of 12-15 years of drug-device combination product experience in the medical device or pharmaceutical industry.
- Demonstrated leadership experience in managing cross-functional teams in bringing medical devices from concept to commercialization.
- Experience in navigating regulatory pathways for combination products.
- Deep insights of market trends, competitive intelligence, and customer needs in the medical device industry.
- Must express a strong interest and track record of mentoring and coaching engineers or other technical employees.
Why Biogen?
We are a global team with a commitment to excellence and a pioneering spirit. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.
We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company.
All qualified applicants will receive consideration for employment without regard to any basis protected by federal, state or local law.
Biogen is an E-Verify Employer in the United States.
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