Global Head of Device Development

Roche•South San Francisco, CA

About The Position

At Roche/Genentech, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and making medicines more convenient and accessible to patients while investing in our planet to reduce the carbon footprint. We are fearless in both decision and action. That is why we come to work each day. Who We Are Pharma Global Technical Operations (PT) is the organization that manufactures and delivers Roche’s groundbreaking therapies to millions of patients worldwide. PT is involved in producing every Roche medicine from the development process through clinical trials and continuing to product maturity. Our organization coordinates all aspects of the production of Roche medicines in all disease areas and dosage forms. Pharma Technical Development (PTD) is an integral part of this mission. As an organization of over 2,500 people globally, PTD is responsible for developing the manufacturing processes, products, analytical methods, and Chemistry, Manufacturing & Controls (CMC) strategies to deliver all new products in Roche’s pipeline. This work encompasses the full range of development functions, including biologics, synthetic molecules, devices, clinical supply chain management, and project and portfolio management. PTD applies leading technical expertise to design, develop, supply, and register clinical-stage products globally, reliably delivering the pipeline and supporting commercial manufacturing operations. We excel through innovation, collaboration, dedication, and mutual respect, continuously improving what we do to ensure Roche’s supply of quality products to patients. We commit ourselves to scientific rigor, technical excellence, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. The Opportunity As the Global Head of Device Development, you are an enterprise leader and a key contributor to the One Pharma Strategy (OPS). You are responsible for realization of the Device and Delivery Systems (DDS) strategy, ensuring Roche remains the industry benchmark for patient-centric delivery technologies. You will lead a strong technical organization of 120 + scientific and engineering professionals with different experiences and backgrounds. Your mission is to transform PTD’s device and combination product capabilities to support an unprecedented late-stage portfolio, driving speed, volume, and technical excellence. You are a member of the PTD Leadership Team and a primary influencer across R&D (gRED, pRED), Product Development (PD), and Global Product Strategy (GPS).

Requirements

Advanced degree in Engineering (Mechanical, Biomedical, or Chemical), Life Sciences, or a related technical field is required.
Extensive years of experience in the medical device, Biotechnology, and Pharmaceutical industry, with at least several years of leading large, complex technical organizations.
Proven track record of navigating the complexities of CMC development from inception through commercialization. Demonstrated ability to evolve the systems, processes, or organizations to maximize the impact.
Broad understanding of drug development, with specific expertise in combination products, human factors engineering, and design controls (21 CFR Part 4, ISO14971, ISO13485, MDR and 21 CFR 820).
Exceptional communications skills and demonstrated ability to influence at the senior executive level and build cross-functional alignment across global boundaries.
Experience in deploying digital tools, AI, or automated systems within a laboratory or manufacturing context.
25-40% international travel required.
Inspiring people leader and passionate for leadership development. Deeply experienced in leading through empowerment and accountability.
Strong ability to role model as a leader and to act as a coach and architect regarding system and process with clear accountability.
Deeply experienced in translating complex technical hurdles into clear portfolio-level business impacts for non-technical senior stakeholders.
Savvy in prioritizing with the portfolio, business, and technical lens. Proven capability in navigating and managing ambiguity.
Ability to evolve the system and processes to simplify at enterprise level.
Proven track record in managing the business and performance of the organization.
Ability to engage in debate constructively with a solution oriented mindset; comfortable to make high-stakes decisions with urgency.

Responsibilities

Strategic Enterprise Leadership & Portfolio Management
Shape the end-to-end platform strategy under DDS, from early-stage design through industrialization and commercial lifecycle management to create a maximum of impact.
Lead and support the company-wide Technical Development (CMC) device portfolio. Ensure breadth and depth of the technical capabilities, shared learning, and continuous improvement culture.
Act as the primary decision-maker for development technology investments and platform selection in conjunction with PT device community leaders. Chair the Global Device Review Forum (GDRF) and serve as a key member of the LSTDC (Late Stage Technical Development Committee) for combination product topics.
Partner successfully with internal stakeholders to influence the external manufacturing network strategy, ensuring contract development and manufacturing organization (CDMO) partners are technically enabled to support patient-centric delivery systems.
Enable "Design for Sustainability" principles of DDS, ensuring new device architectures are compatible with future environmental standards and circular economy initiatives.
Device Community Architecture & Influence
Lead the Global PT Device Community in a "Collective Leadership" model. Partner and collaborate deeply with the Device and Packaging Industrialization (MSAT) teams, Pharmaceutical Development, Device Quality, and Regulatory to ensure an integrated approach to combination product health.
Forge strong and reliable relationships with Head of R&D units (gRED, pRED), PD, and GPS. Influence clinical development strategies to ensure device platforms are integrated early and effectively.
Act as an executive representative with Global Health Authorities and external strategic partners. Lead the external influencing agenda for combination product regulations and standards.
Next-Gen Innovation & Technical Excellence
Accelerate the development of the "Next Generation" of device platforms, including and not limited to, high-volume Auto-Injectors (3-5mL), pen platform, and high volume delivery system.
Embed Data, Digital, and AI capabilities into your leadership and successfully into device design.
Transition and further shape the organization toward a "Lab of the Future" model, utilizing predictive modeling and automated testing to accelerate design verifications and exceptional user experiences to the next level.
Operational Excellence & High Performing Organization (HPO)
Instill a culture of technical rigor to eliminate operational friction and raise process efficiency. Ensure all foreseeable risks are identified early and mitigated with urgency (Right First Time (RFT)).
Drive Lean/Operational Excellence (OE) principles to achieve productivity goals, by leveraging platform knowledge and design histories.
Actively motivate, mentor and develop "Ready Now" successors and rising stars. Foster an inclusive environment that reflects Roche’s commitment to inclusion & belonging. Embody and role model Roche values and VACC (Visionary, Architect, Catalyst, Coach) leadership principles.