About This Role

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 with the ambition to develop, scale and maintain best-in-class drug-delivery systems. 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. We will continue to pioneer solutions to overcome the blood brain barrier and evolve best in class peripheral delivery solutions.

What You Will Do

As the Director of Device Strategy & Early Programs you will play a pivotal role in leading our efforts to develop state-of-the art drug delivery systems that have the potential to transform the way medications are delivered to patients. 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 that will help patients and healthcare workers deliver our innovative medicines and vaccines.

This role requires a strategic thinker with business acumen, a visionary leader with cross-functional perspective, and a deep technical expert. This role involves close collaboration with R&D senior leadership, the Commercial business teams (Rare, MS, AD etc) as well as Manufacturing and Supply leadership to deliver device technologies that enhance the value of the drug and provide competitive advantage.

• 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 by influencing and ensuring fluid communication regarding longer term operational objectives, portfolio priorities, progress, and critical issues. 
• Facilitate gathering of cross – company inputs to guide and refresh device strategy roadmaps by applying strong business acumen and ability to evaluate changing business conditions and clinical data, effectively shifting strategy and priorities.
• Stay abreast of the technology and Regulatory landscape and compliance standards applicable to the global target markets of Biogen’s drug-device portfolio, to ensure seamless product development and compliance with industry standards and regulations.
• Lead the generation and publication of patient preference and health economic evidence to guide and support investment decisions, Regulatory Agency and Payor queries.

Who You Are

You have a track record of fostering innovation and solving complex technical challenges in medical device development to drive business impact and growth 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 with a demonstrated track record of success.
• Demonstrated leadership experience in managing cross-functional teams in bringing medical devices from concept to commercialization. Executive-level experience leading product development organizations highly desired.
• Experience in navigating regulatory pathways for combination products, and leading team through successful submission and approval of regulatory filings.
• Deep insights of market trends, competitive intelligence, and customer needs in the medical device industry.
• While this is an individual contributor role, individual must express a strong interest and track record of mentoring coaching engineers or other technical employees.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.