Director, IVD Product Development
- 505 Penobscot Dr, Redwood City, CA 94063, USA
ABOUT OUR COMPANY
We believe conquering cancer is a big data problem. That’s why we built the world’s leading comprehensive liquid biopsy. This non-invasive tool for accessing and sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. We’re working on some exciting ones, including in early detection, where the impact on patients can be profound. We’ve raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, and SoftBank.
To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening, the Product Development Team seeks a highly motivated Director, IVD Product Development to manage all aspects of the IVD product development, involving multiple technical fields with cross-functional leadership in R&D, product and process development, validation, tech transfer, manufacturing operations, quality, and regulatory affairs.
This a newly created leadership opportunity for a product leader who has a proven track record of new product development and driving successful transfer of projects from the R&D phase into manufacturing and through commercialization.
As the Director, IVD Product Development, you will be the go-to for management of the business processes from inception to commercialization of In-Vitro Diagnostics products and timelines required to meet regulatory milestones. You will also participate as a key member of the Product Development leadership team and the FDA Steering Committee.
You will contribute to the development of IVD strategies and regulatory analyses for various options for senior management consideration, ensuring that the right pathways are selected and executed. You will lead IVD development activities in support of collaborations with pharmaceutical companies and take responsibility for development of program milestones for development of companion diagnostics tests (IVD) sponsored by pharmaceutical companies.
Partnering with biostatisticians, scientists and lab technicians, as well as key executive stakeholders, you’ll build new product development processes and extend existing ones to meet corporate objectives while ensuring compliance with regulatory requirements.
- Build IVD product development processes from the ground up and lead cross-functional teams to deliver corporate objectives in a fast pace start-up and regulated (ISO, QSR) environment.
- Lead the new IVD product development and phase gate process implementation, including
- Process mapping
- Design control implementation
- Risk management
- Project management
- Technical IVD program management and documentation writing
- Development and management of the writing of project design control plans and technical documentations
- Lead a cross-functional team of scientists, software developers and process engineers to meet regulatory requirements for product filings
- Advise on product features to improve regulatory adherence
- Facilitate the definition of project scope, goals and deliverables
- Define project tasks and resource requirements
- Supervise and support the development of the Design & Development Plan
- Oversee creation of and management of Design History File. Design review records; Risk Management Files, and project documentation
- Monitor and report on progress of the project to all stakeholders
- Manage external collaborators to deliver tools, experiment designs and processes that accelerate product development
- Develop product development strategy that effectively integrates with the corporate, regulatory and clinical strategies
- Act as an interface between Product Development, Medical Affairs and Regulatory Affairs
- Analyze data and troubleshoot issues within the clinical operations, tech development, bioinformatics and process engineering teams
- Engage in early design of products
- Present updates, write reports and SOPs, and contribute to technical discussions
- You’re dedicated to making a difference and are driven to make a positive impact in cancer diagnosis and treatment. You are a self-motivated, well-organized individual who is excited by the prospect of working in a dynamic, fast-paced environment. You bring a can do attitude to solve new and challenging problems in a high pace environment
Your background includes:
- A minimum of 10 years of experience in product development and project leadership, IVD experience strongly preferred
- Experience with technical and scientific cross-functional team leadership
- Excellent written and oral communication skills
- Local candidates in San Francisco Bay area are preferred.
- Education: BSc or higher in biology, engineering or related areas. Equivalent experience will be considered.