Senior Director of Development

Why join Freenome?

Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. 

Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning. 

Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.  

At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.

Become a Freenomer

Do you have what it takes to be a Freenomer? A “Freenomer” is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients’ lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what’s possible, one breakthrough at a time.

About this opportunity:

We are seeking an experienced Late Genomics Development leader to help Freenome achieve its ambitious goal to detect, prevent and treat disease in its earliest stages. The ideal candidate is a leader with a proven track record of leading development programs in a regulated IVD environment, launching diagnostic products and growing organizations to achieve their full potential. This person is responsible for all things related to late genomics development, Systems Integration, and Scientific Operations.  You are passionate about improving patients’ lives by delivering first-class diagnostic solutions, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

The role reports to the VP of Development, and is an Hybrid role based in our Brisbane, California headquarters.

What you’ll do:

• Work closely with the early genomics team to take product designs through Freenome’s product development lifecycle
• Collaborate with Regulatory Affairs, Computational Science and Operations to develop, plan and execute analytical validation/design verification activities
• Partner with other scientific leaders and executives at Freenome to develop a product development strategy and scientific roadmap, and provide strategic guidance, direction, and support the users of Scientific Operations facilities
• Establish and implement short- and long-range organizational goals, objectives, strategic plans, policies, and operating procedures; monitor and evaluate programmatic and operational effectiveness, and drive changes required for improvement
• Advise the leadership team on best approaches to reaching product development milestones and oversee their timely achievement; manage program risks effectively and develop mitigation strategies to retire the risks
• Provide leadership to a talented team of IVD, study execution scientists, Systems Integration Engineers and Scientific Operations staff

Must haves:

• PhD in biological sciences (or MS in biological sciences with equivalent industry experience) with at least 12 years of experience directly related to IVD product development, and 6+ years directly managing teams including 4+ years in a Director role
• Proven track record of developing, validating and launching multiple IVD products in compliance with US 21 CFR Part 820, ISO 13485, CLSI guidelines and other relevant medical device regulatory standards and guidelines
• Demonstrated ability to strategically manage all technical and operational aspects of a complex, high-tech product development programs
• Technical grasp of genomics (NGS assays for DNA and/or RNA, including extraction methods and library preparation workflows)
• Demonstrated ability to develop and manage project timelines, budgets, resource utilization, and prioritize activities across multiple complex projects
• Skills in examining and re-engineering operations and procedures, improving processes, formulating policy, and developing and implementing new strategies and procedures to improve operational efficiency, on-time delivery and efficient resource utilization
• Clear communication skills and ability to lead and work with cross-functional technical