Director, Project Lead

Summary

Join Natera as a Project Lead and drive the development and launch of ECD products. Lead and motivate cross-functional teams, ensuring alignment on resources, budget, and timelines. Resolve challenges during product development, validation, design transfer, and launch. Collaborate with various departments, including R&D, Quality Assurance, and Regulatory Affairs, to ensure compliance. Manage the Product Manager for development, providing guidance and mentorship. Act as the project team's point of escalation to executive leadership. Manage partner expectations and communicate potential delays or changes.

Requirements

• MS or PhD in Molecular Biology, Genetics, Computational Biology, or a related field
• Minimum 5 years of experience within the biotechnology or life sciences industry
• Experience in Program Management and/or Product Development in diagnostics industry, Early Cancer Detection preferred
• Experience in product development under design control in a regulated environment (FDA, IVDR)
• Proven record of developing and overseeing the execution of development programs from concept through to a successful product launch that have led to long-term, sustainable success
• Detailed knowledge of clinical product development in oncology
• Experience working with and managing external partnerships and collaborations
• Ability to explain complex technical details in clear language
• Ability to work both independently and as part of a team
• Technical proficiency and creativity
• Excellent verbal and written communication skills, specifically in presentations

Responsibilities

• Leads, motivates, and organizes the project team, including the Product Manager for development, to define and execute on development plans that meet the stated timelines for delivery of the product
• Collaborates with Program Managers to run meetings and events to ensure team ownership and commitment to product plans
• Drives cross-functional project teams and functions, including R&D and product management, to align on solutions and alternative courses of action to resolve development issues including specification trade-offs, risks, and process compliance
• Rapidly resolves critical issues that impact the project plan and product delivery
• Ensures optimal team membership so that the team has full functional expertise to execute on the project plan
• Leads the team to identify key technical, timeline, and business risks to the project and implement innovative risk mitigations
• Collaborates closely with Quality Assurance, Clinical Operations, and Regulatory Affairs to develop strategies to ensure compliance with all relevant regulations including QSR, GMP, GCP, IVDR, PMDA, and CLIA/CAP
• Manages the Product Manager for development, providing guidance, mentorship, and oversight to ensure successful product development and alignment with project goals
• Acts as the project team point of escalation to executive leadership
• May drive other aspects of early innovation project development in conjunction with R&D, ensuring seamless integration of scientific advancements into the product development process, and facilitating knowledge transfer between R&D and collaborators
• Manages partner expectations and understands key program dependencies and changes, proactively communicating on potential delays or changes

Preferred Qualifications

>10 years of experience preferred

Benefits

• Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more
• We also offer a generous employee referral program!