Global Head of Device Development

Roche

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profile Job Location:

Basel - Switzerland

profile Monthly Salary: Not Disclosed
Posted on: 3 days ago
Vacancies: 1 Vacancy

Job Summary

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

At Roche/Genentech we believe its 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 Roches 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 2500 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 Roches 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 Roches 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 PTDs 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).

Key Responsibilities

1. 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.


2. 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.

3. 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.

4. 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 Roches commitment to inclusion & belonging. Embody and role model Roche values and VACC (Visionary Architect Catalyst Coach) leadership principles.

Who You Are

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.


Leadership Competencies

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.

Where pay transparency applies details are provided based on the primary posting location. For this role the primary location is Basel. If you are interested in additional locations where the role may be available we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.


Lets build a healthier future together.

Roche is an Equal Opportunity Employer.


Required Experience:

Director

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim...
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About Company

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F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.

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