Head of Device Development - #9805502
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 drug – device combination products. You have the ability to connect with all levels of the organization to influence while embracing and driving change. You have a passion for driving technical excellence in everything from product conceptualization, throughout product development cycle to regulatory submissions that ultimately deliver life changing therapies to patients.
- Master’s degree in engineering with at least 15 years of relevant experience. Equivalent experience equals a bachelor’s degree and 20+ years of relevant experience (PhD and comparable experience may also be considered)
- Experience in drug-device combination products and related regulations in the medical device or pharmaceutical industry.
- Deep knowledge of ISO13485 and Quality System Requirements, applicable Industry and Regulatory Standards and Guidance Documents
- Applies a high degree of business acumen and technical judgment to solve problems
- Demonstrated track record of successful end to end device development
- Strong project management skills
- Exceptional people leadership track record in a matrixed environment including mentoring, coaching & motivating engineers
- Strong stakeholder management and negotiation skills when working with internal and external partners
- Excellent verbal and written communications skills, with technical or multi-functional audiences
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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.