Project Lead

Roche • Indianapolis, IN

3d • Hybrid

About The Position

At Roche, we foster a culture where individuality is celebrated, and open dialogue is encouraged, leading to genuine connections. We value, accept, and respect everyone for who they are, enabling personal and professional growth. Our mission is to prevent, stop, and cure diseases, ensuring universal access to healthcare for present and future generations. Join Roche, where every voice matters. The Insulin Therapy Solutions division is committed to delivering world-class products for individuals with diabetes. We adopt a holistic approach, managing our product portfolio from conception through development, market introduction, and eventual phase-out. This involves in-house developments, strategic partnerships, and collaborations. We achieve our objectives through close, collaborative partnerships with all global functions at Roche Diabetes Care and the broader Roche family (Dia and Pharma). As a Project Lead, you will serve as the global business lead within the new Continuous Monitoring Lifecycle Team (LCT), focusing on FDA approval for our CGM Solution. You will be the primary point of contact for affiliates regarding the introduction of our CGM Solution into the US market and will lead the associated project team. In this dynamic and diverse role, you will report directly to the Lifecycle Leader (LCL). Your strategic responsibilities will include introducing a new medical device (CGM) in the US market. You will be accountable for decision-making, leadership, planning, and ensuring the efficient and effective utilization of resources. Success will be achieved through managing executives, professionals, and/or support staff. You will define the strategy for your department and hold full HR responsibility for your employees.

Requirements

• Degree in science, engineering, or equivalent (MBA or PhD is an advantage).
• +8 years of relevant professional experience in project management and leadership.
• 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).
• Leadership skills in managing multidisciplinary teams in a global matrix environment.
• Experience in developing and building teams, and managing change and conflict resolution.
• 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).
• Clear communication, accurate presentation, and stakeholder-oriented communication in front of large groups.
• Confidence in dealing with customers.
• Excellent written and spoken English communication skills.

Responsibilities

• Provide cross-functional leadership and management to ensure product launches are delivered on time, within budget, and to specification (All projects, including PCQT projects).
• Ensure planning and adherence to budgets, timelines, risk mitigation plans, and resources in coordination with stakeholders in Finance, Project Management, Operations, and R&D.
• Develop global product development strategies from project initiation to the market launch decision.
• Develop strategic options based on the principles of time, cost, and risk, considering technical, regulatory, business, and operational requirements.
• Communicate the risks associated with solution development and the implementation of risk mitigation plans.
• Lead, motivate, and organize the project team (based on Roche leadership principles) to define and implement an innovative and sustainable project strategy aligned with LCT objectives and budget.
• Demonstrate leadership skills among PL colleagues to drive cross-LCT and CA/BA project discussions, foster a positive environment, encourage creative or unconventional ideas, and ensure their utilization by the team.

Benefits

• Pay transparency 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior