Senior Director - Medical Device Development at Tempus
Passionate about making a difference in using data to improve how cancer patients are treated?
With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but doctors and researchers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how genomic data is used to fight cancer. We are looking for a Senior Director - Medical Device Development to join our rapidly growing Tempus team.
What You’ll Do
In a nutshell, your job is to lead and project manage our process for taking submissions to the FDA, through product design and development, to regulatory submission, and commercial launch. You will need to have a deep understanding of the teams’ deliverables and processes, the ability to learn the regulatory requirements and expectations, and the skills to drive numerous projects forward accordingly.
You are a dedicated and well-rounded athlete who will work to solve problems, communicate issues, mediate discussions, set meeting agendas and facilitate accountability across the organization. If you are successful, you are so on top of the day-to-day issues and tasks associated with the regulatory submission and approval process that you provide cross-functional leadership with more bandwidth to focus on launching and streamlining the workflows required to support launch.
- Project Management: You are excited to work on time sensitive and high complexity projects. You’ll be involved in multiple projects at a time and need to understand what is most important and how to prioritize. You know how to triage and you love delivering results
- Execution: Work with R&D, quality, regulatory, technical, and product teams to ensure we are functioning at the highest of levels, focusing on the most important things, solving problems as they arise, and communicating effectively across teams and upwards to leadership on project progress.
- Strategy and Planning: You will help the cross-functional team focused on FDA submissions to execute on their short term and long term goals and be open and honest with leadership to identify areas that need attention and/or improvement. You’ll be able to figure out when projects might go off track and what needs to be done to get them back on the rails.
The successful candidate for this role will be:
- A strong and open personality: You work well with experts in different disciplines. You are independent, strategic, humble, and comfortable creating structure out of ambiguity. You are comfortable asking questions, working with various types of stakeholders, and living on a steep learning curve. You are happy to dig in to new areas.
- Clear communicator: Shows exceptional project management, articulation of issues and an ability to navigate Tempus stakeholders across teams to solve problems. You know when to give a heads up on an issue and when to let things play out to resolution.
- Action-oriented and organized: Proactive mindset that bridges ideas to implementable solutions, and can help move both internal and external stakeholders to quickly solve problems.
- Results-focused: Focused on tackling hard problems to identify the most important components, getting the answer and executing.
- 10+ years of experience as a skilled operator with project management experience
- Experience working on medical devices and/or clinical laboratory assays