Define and execute the end-to-end strategy for drug-device combination product development aligned to portfolio goals, inclusive of concept, clinical, commercial and lifecycle management of combination product presentation
Influence and translate early molecule needs into device roadmaps and delivery strategies with an emphasis on subcutaneous delivery.
Own technical execution of design control process with hands-on leadership of prototyping, verification and validation activities.
Lead root cause investigations, deviations and CAPAs
Solve complex technical challenges in drug-device integration and delivery performance to ensure robust device performance, reliability and manufacturability.
Ensure integration of drug product and device components to drive system-level architecture and interface definition.
Lead and develop multidisciplinary engineering teams that serve as device subject matter experts and are both external facing to device manufacture and internal facing to combination product development teams to innovate and develop device solutions.
Identify and mitigate technical, regulatory and supply risks through implementation of design and process risk controls, risk management and problem solving.
Manage prototyping and device development laboratories to accelerate design and risk reduction.
Drive robust, data-driven decision-making through model-informed development practices.
Enhance Biogen's internal and external recognition in combination product development.
Inform regulatory strategies and participate in regulatory meetings as needed.
Develop strategic relationships with key external partners and stakeholders.
Represent Biogen in external industry forums to elevate the organizational voice.
Ensure alignment and integration in planning and milestone delivery across development programs.
Requirements
Required Skills:
Bachelor's degree in Engineering with at least 15 years of relevant experience. Equivalent experience may also be considered (MS+12 years of experience or PhD+ 8 years of experience).
Extensive experience in drug device combination product development within the medical device and pharmaceutical industry.
Ability to lead and influence across matrixed organizations.
Deep understanding of root cause investigations, human factors, regulatory requirements, and device design controls.
Proven track record of developing strategic device solutions and managing complex technical projects.
Experience with model-informed development practices and digital twin simulation.
Established external network within the subcutaneous drug delivery device ecosystem.
Strong ability to anticipate business needs and inform device strategies.
Strong communication an
Additional Information
About This Role:
As the Senior Director of Device Development within Product Delivery Solutions, you will play a pivotal role in leading the selection, technical development, and lifecycle management of device drug delivery platforms. Primarily focused on drug-device combination product development such as prefilled syringes, autoinjectors, and on-body delivery systems, you will advance both novel and platform-based technologies from concept through commercialization. By driving collaborations and innovation, you will enhance patient experiences, clinical performance, and competitive positioning of Biogen's multi-modality portfolio of therapeutic assets and indications. Among other routes of administration, you will own the subcutaneous device technical development and device related risk management strategy across various programs, influencing enterprise investment decisions and ensuring the organization remains competitive in the subcutaneous and home-use ecosystem.
Your leadership will span a multidisciplinary engineering organization, expanding computational modeling capability, overseeing prototyping and device development laboratories to foster trouble shooting, iterative design and scalable platforms. Your role will be instrumental in shaping cross-functional combination product architecture, championing patient-centric innovations, and ensuring operational rigor within the global clinical, quality and regulatory frameworks.
This is a hybrid role to be based at our Headquarters in Cambridge, MA.
Biogen · Cambridge, MA