The Technical Device Development function is a key component of Genenetech and Roche’s Pharma Technical Development organization, providing technologies and strategic support for development and commercialization of a portfolio of combination products. Technology development is directed towards enabling product teams to enable and differentiate our products and ensure Roche is highly competitive in commercial markets.
The Device Development Head is accountable for a project portfolio that consists of approximately 25 development projects and several commercial products in a variety of therapeutic areas including immunology, ophthalmology, oncology, neuroscience, metabolism and infectious diseases. The Head is expected to set and implement strategies desired to drive state of the art technical and product development capabilities including influencing clinical development strategies to enable combination product team success. Technology development is geared towards developing devices that enable products in these diverse areas and ensures ongoing competitiveness.
The Head must provide effective oversight of an extensive network of external technology and development partners to ensure technology solutions and development programs meet business objectives. The Head of Device Development US partners with their counterpart in Europe and stakeholders in Roche’s global network to maximize effectiveness in managing the Roche combination product portfolio, including cross-functional efforts to select technologies, drive improvements in device product quality, ensure robust manufacturability, enable lifecycle management, and consistently meet evolving health authority expectations. Specific responsibilities include:
Development and application of a broad range of drug delivery devices, including pre-filled syringes, needle safety devices, auto-injectors, patch infusers, intraocular delivery devices/tools. Additional Drug delivery technology development areas of responsibility include pulmonary drug delivery, manual injection systems, Smart Devices/electronic tools for therapy adherence, and will include other new technology areas in the future.
Perform assessments of new technologies and market trends. Utilize information to inform technology development and provide input to Marketing/Commercial strategies as needed.
Make technology investment decisions to meet budget and business needs. Develop and maintain a current technology strategy - investment decisions based on portfolio needs and market trends in collaboration with key senior level stakeholders in PTD, PD and GPS.
Oversight of various Development sub-functions within the Device organization:
Device and Primary Container Design Engineering, including selection of devices to be developed and marketed commercially, evaluation and definition of patient needs, device design/customization and engineering, device clinical testing support and writing sections of health authority filings.
Human Factors Engineering function, which executes the human factors engineering studies for all project teams developing and commercializing a device. This responsibility additionally entails the establishment and continuous improvement of human factors business processes, global internal alignment of approaches for human factors testing, and external influencing of health authorities on best practices in this area.
Device Process Engineering with responsibility for clinical and commercial device assembly process engineering and manufacturability, technology transfer support, product care and commercial manufacturing support, for both the Roche internal manufacturing network and external development/manufacturing partners.
Device Laboratory Operations, which performs analytical characterization and Design Verification testing for all devices and projects in the department.
Design Control function that is responsible for effective execution of Design Control processes and documentation to ensure compliance with global health authority requirements (e.g. FDA 21 CFR Part 4) and technical standards.
Device Project Management and portfolio management
Business process ownership and governance processes for Device Development
Managing and annual budget of $25-30MM to meet financial goals and facilitate acquisition of resources / prioritization of workload.
Broader organizational accountabilities include:
Chair Device Technical Advisory Committee (DTAC), which is accountable for guiding the device strategy and technology development plan for specific development products in US development portfolio.
Represent Device Development in global Technical Development governance forums.
Ensure alignment with Technical Device Development-Europe on technology and operational initiatives Ensure effective communication with research, development and commercial stakeholders across the company to ensure common understanding of the device project portfolio, share current status/issues for projects with respect to meeting product development deliverables and timelines, and sharing technology development progress. This includes, but is not limited to, holding annual DTAC Portfolio Review, publishing regular status reports, joint leadership team meetings with functional counterparts, etc.
Chair External Influencing Steering Committee (EISC) Device Topic Area with the objectives of influencing and shaping global health authorities expectations on key industry topics (cGMPs for combination products, human factors, clinical testing of devices, adverse event reporting, marketing application filing approaches and other topics).
Member of the US Pharma Technical Development Leadership Team, including Bioprocess, Analytical and Pharmacuetical development. Expected to serve as a sponsor to technical development teams beyond the area of devices, and engage in organizational initiatives and leadership in a collaborative manner.
Accountable to ensure quality and accuracy of Device sections of Regulatory submissions and communications.
Accountable to assure processes and systems are in place Project team Design History Files meet regulatory requirements and readiness for health authority inspection; ensures effective remediation plans for compliance assessments and audits.
Relationship building is key for this role. The leader must be customer focused and have a deep commitment to working collaboratively to support the global Roche portfolio. As such, the leader will foster an environment of cross-functional collaboration, accountability, and technical rigor in collaboration with the EU Head of Device Development. The successful candidate will provide regular, visible leadership in advancing new device platform technologies and ensuring a positive external reputation in combination product development. The leader must influence across functions to facilitate the overall enhancement of organizational capabilities in device/combination product development in Pharma Technical. This responsibility includes ensuring effective interfaces with Marketing, Quality, Regulatory, Manufacturing, Clinical Development and counterpart technical groups. The leader is responsible for a staff of a growing organization of approximately 80 staff (insourced and regular employees) and technical management of a complex network of numerous (~50) external company partners.
Who You Are
20+ years industrial experience in biotech product development, with at least 10 years of significant leadership/management experience in the area of devices and combination products.
Demonstrated achievement in the successful development and commercialization of device technologies, innovation, and championing business practice improvements.
Demonstrated strategic thinking and influencing internally and externally
Demonstrated ability in organizational leadership and capability development.
Passionate about bringing a quality mindset to everyday work and ensuring full use of Lean/Six Sigma principles to drive continuous improvement.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our em...ployees are our most important asset & are dedicated to remaining a great place to work.
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