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

In Roches Pharmaceutical Research and Early Development organisation (pRED) we make transformative medicines for patients in order to tackle some of the worlds toughest unmet healthcare needs. At pRED we are united by our mission to transform science into medicines. Together we create a culture defined by curiosity responsibility and humility where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

Strategy Portfolio & Operations (SPO) is a function that aims to encompass a number of enabling functions for pRED including strategy portfolio project management clinical operations sites and laboratory management capability development and external operations. SPOs mission is to deliver excellence in operations ensure patient centricity and enable high quality decision making. As a trusted partner across pRED SPO contributes along the discovery and early development value chain to ensure we are maximising R&D Productivity.

Job Mission:

The Head of Global Clinical Operations - pRED is accountable for providing a comprehensive strategy and provides strategic and operational guidance oversight and effective delivery for all clinical programs across pREDs entire clinical portfolio. The Head of Global Clinical Operations - pRED works in close partnership with Senior Leadership in pRED Discovery & Translational Areas (DTAs) and global functions in addition to Roche global functions as well as other key internal stakeholders to align and deliver the Clinical Operations strategy and ensure portfolio delivery. He/She works with internal and external resources to ensure that clinical studies are conducted according to high standards that meet rigorous regulatory and GCP guidelines. He/She is accountable for developing the clinical operations group/chapter and is accountable for developing and sustaining scalable business processes aligned with the Roche enterprise to ensure innovation and efficiencies in overall clinical trial delivery.

The chapter with around 80 employees consists of clusters set up to ensure high quality and ICH/GCP compliant clinical programs from entry into human to pivotal programs. Clusters within the clinical trial chapter include the clinical trial program chapter clinical trial expert chapter quality and compliance chapter as well as portfolio leads technical enablers and patient partner roles.

Reporting to the Head of Strategy Portfolio & Operations (SPO) the Head of Global Clinical Operations - pRED is a key member of the SPO leadership team and the Early Strategic Portfolio Committee (eSPC). He/She collaborates closely with senior leadership across various functions to ensure that clinical studies are conducted to the highest standards fostering innovation and efficiency in clinical trial planning and execution.

Primary Responsibilities and Accountabilities:

• Accountable for developing and delivering the Clinical Operations vision and strategy to drive successful delivery of the pRED clinical portfolio.
• Lead and manage the early development pRED clinical portfolio overseeing the strategy planning and execution of all clinical programs
• Fiscal responsibility to establish and manage the overall Clinical Operations budget and headcount costs in alignment with pRED requirements
• Responsible for building and enabling the development of the pRED Clinical Operations community
• Serves as a principal spokesperson for Clinical Operations in Governance Review bodies and is the decision-maker for Clinical Operations
• Build highly collaborative relationships with other functional Leaders and key stakeholder by establishing himself/herself as a strategic thought partner
• Sponsor Early Clinical Development initiatives to proactively identify new opportunities to leverage Clinical Operations core competencies and develop ways to improve clinical trial processes systems and tools
• Serves as a key technical expert and participate in enterprise initiatives to support and influence the future direction of the company
• Collaborate very closely with other Roche/Genentech Clinical Operations Heads to find synergies and efficiencies on clinical trial processes sourcing models and other operational imperatives

Your Impact:

• Creating vision and strategy for the chapter that is aligned with the overall pRED and Roche strategy. Oversight and overall accountability for the pRED clinical trial programs operations. Guiding the chapter and partner DTAs / functions towards patient focus lean clinical programs and high quality execution.
• Accountability for ICH/ GCP clinical trial conduct CRO management (in / outsourcing of clinical programs) and changing regulatory requirements.
• Partner with stakeholders across pRED and other Roche functions such as PDG PT gRED etc.
• Continuously evolve pREDs ability to deliver cutting edge clinical programs leveraging new technologies regulatory requirements capabilities and healthcare ecosystem changes.

Your Profile:

You thrive in a dynamic inclusive environment which gives you full accountability for your own contributions and development. You have a keen interest in continuously building a personal network. You are resourceful and flexible in problem solving and in working in a collaborative and inclusive manner. You have a sense for ensuring that everyone has the required information at all times.

Your extensive professional experience in the field of clinical operations allows you to expertly guide and architect clinical programs guide complex organizations and clinical trial operations as well as cross functional teams. You have worked in matrix organizations and proven your understanding of the science and business context of drug discovery & development.

Key experience and background:

• 15 years of experience in the pharmaceutical industry in clinical trial operations. Ideally with experience in all aspects of clinical operations including business support functions from strategic development to effective execution.
• 10 years of experience in strategic senior leadership roles leading people (including leading matrix teams) and larger groups and recognized for embracing new ways of leading and working with strength in coaching and fostering a collaborative environment in which scientists can be bold innovate and do their best possible work.
• Track record in contributing to collaborative efforts across organizational boundaries.
• MD PhD PharmD or DVM degrees are preferred.

Our commitment:

Roche commits to recognizing talent and aptitude. We prioritize encouraging and supporting our employees on their personal journeys by providing a safe creative space to help them reflect make decisions and grow in their career.

We are confident that we find the most innovative solutions by gaining different perspectives asking and answering hard questions and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds perspectives and skills. The more inclusive we are the better our work will be.

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.