Head of Device Development

Job Description

The head of the device development group is responsible for the development of state-of-the-art drug delivery systems that have the potential to transform the way medications are delivered to patients.  You will lead a team of highly skilled engineers and scientists in the end-to-end development, commercialization and life cycle management of devices, used across the multiple disease indications and modalities of Biogen’s clinical and commercial portfolio.  The product scope includes Class 1-3 medical devices for multiple routes of drug administration.  The therapeutic modalities include but are not limited to small molecule, oligonucleotide and biologics.   The responsibilities also include optimizing the infrastructure, design control processes, and technical capabilities needed to lead the industry in drug-device combination product therapies that are user-centric, innovative, reliable and environmentally sustainable.  The development of combination products and medical devices is a highly cross-functional exercise that requires coordination and input from multiple functions across Biogen and external partnerships. 

In addition to leading the device development function, the head of the device development group will lead the technical evaluation of novel device technologies, setting the strategy for the Device Pillar within Biogen. The Head of Device Development engages with a cross-functional team of experts from regulatory sciences, pre-clinical, safety, clinical development, clinical operations, medical affairs and clin pharm. This team is accountable for the successful integration of the platform device in the relevant clinical assets’ plans. Importantly, the head of device development will coach, mentor and develop team members to ensure goals are accomplished, organization objectives are met and team members are empowered and successful.

What You’ll Do

• Lead in the development of new and innovative device technologies, processes, solutions, and products
• Provide leadership, develop strategic direction for the department to ensure business and technical objectives are met
• Direct people management responsibility internally and external resources to develop, test and manufacture devices/combination products
• Coach and mentor team members on successful integration of device development, combination product verification and validation testing in clinical development and commercial launch plans
• Search and evaluate external landscape for drug delivery device technologies to recommend device strategies for clinical and commercial assets
• Lead cross-functional teams of senior leaders to align strategies related to device development and advance innovation such as implantable devices across all modalities for clinical and commercial assets
• Liaise with external partners to ensure on-time and high quality execution of development and manufacturing activities for clinical and commercial assets, and commercial supplies continuity
• Develop support strategy for programs or platforms with key business partners in support of the analysis of highly complex issues in a technical area and establishes resolutions/decision points in a given program/project.
• Advise management and key stakeholders, and provide key input in broad ranging strategic projects including operational excellence and business development opportunities (e.g. combination product roadmap, continuous improvement, device selection, external partners opportunities )
• Inform regulatory strategies, author and / or approve regulatory filings and briefing documents, and represent Biogen in face-to-face meetings with regulatory agencies as needed
• Establish plans for talent development, diversification, and professional development for employees
• Functions as engineering SME in single or multiple engineering topic(s).
• Supports the development and validation of departmental, project and program budgets and goals
• Identifies novel and nascent technically innovative opportunities, developing IP as appropriate
• Establish external partnerships and collaborations with vendors and SMEs to advance specific projects.
• Applies a high degree of business acumen and technical judgment to product and process improvement
• Communicates overall strategy of the projects and initiatives to other stakeholder, both internally and externally

Who You Are

You are an experienced leader with the ability to lead teams through uncertainty in a dynamic environment. You should have a deep understanding of all aspects of medical device development and manufacturing processes for assembly of medical devices. You also have a strong knowledge of implantable devices and new commercial devices introduction, regulatory and compliance requirements of device design controls and dru