Project Lead

Roche Insulin Therapy Solutions

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

Our Insulin Therapy Solutions division is dedicated to providing world-class products for people with diabetes. We work with a holistic approach, which means that we take care of our product portfolio from the idea, through development and bringing products to the market, to phase-out. This includes in-house developments, strategic partnerships and collaborations. We achieve our goals in a very close and collaborative partnership with all global functions at Roche Diabetes Care and the entire Roche family (Dia and Pharma).

As Project Lead you will act as global business lead in the new Continuous Monitoring Lifecycle Team (LCT) with focus on FDA approval of our CGM Solution. You will be the central point of contact for colleagues from the affiliates for questions regarding the introduction of our CGM Solution into the US market and will lead the corresponding project team. In this exciting and diverse role, you will report directly to the Lifecycle Leader (LCL).

You will take on the strategic task of introducing a new medical device (CGM) in the US. You will be responsible for decision making, leadership, planning and ensuring efficient and effective utilization of resources. You will achieve success by managing executives, professionals and/or support staff. You will set the strategy for your department and have full HR responsibility for your employees.

The Opportunity

• You will be responsible for providing cross-functional leadership and management to ensure product launches are delivered to timelines, budgets and specifications (All projects (incl. PCQT projects).

• You will ensure planning and adherence to budgets, timelines, risk mitigation plans and resources in coordination with stakeholders in Finance, Project Management, Operations and R&D.

• You will develop global product development strategies from project initiation to the market launch decision. In particular, you will develop strategic options based on the principles of time, cost and risk, taking into account technical, regulatory, business and operational requirements.

• You will communicate the risks of solution development and the implementation of risk mitigation plans.

• You lead, motivate and organize the project team (based on Roche leadership principles) to define and implement an innovative and sustainable project strategy in line with LCT objectives and budget.

• You will demonstrate leadership skills among PL colleagues to drive cross LCT and CA/BA project discussions, create a positive environment, encourage creative or unconventional ideas and ensure they are utilized by the team.

Who You Are

• Degree in science, engineering or equivalent (MBA or PhD is an advantage).

• +8 years of relevant professional experience in project management and leadership and ideally more than 6 years of relevant professional experience in diagnostics or pharma in development or operations.

• Experience in MDR and IVDR, references regarding product approval projects in the US (510k or equivalent)

• You have leadership skills in managing multidisciplinary teams in a global matrix environment: Here you have experience in developing and building teams and manage change and conflict resolution.

• You have proven experience with (FDA) projects in the range of the portfolio (FDA relevant study planning and execution, FDA approval processes, as well as experience in interacting with the US FDA)

• You communicate clearly, present accurately and stakeholder-oriented in front of large groups and are confident in dealing with customers. You also communicate excellently in English, both written and spoken.

This position requires approx. 25% travel time and can be filled in Mannheim (Germany), Indianapolis (USA) or Rotkreuz (Switzerland).

We look forward to receiving your application!

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Rotkreuz. 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 100'000 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.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.