Director, ECD Project Lead

POSITION SUMMARY: 

The Project Lead is a highly visible and strategic role responsible for driving the development and launch of Early Cancer Detection (ECD) products. This role demands a proactive leader who can provide strategic direction, motivate cross-functional teams, and ensure alignment on resourcing, budget, and timelines to meet technical, regulatory, business, and operational needs. The Project Lead will drive team debate in order to determine strategic options and resolve challenges during product development, validation, design transfer and launch.

PRIMARY RESPONSIBILITIES: 

Development Project Lead

• 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.

QUALIFICATIONS:

• 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.  >10 years of experience preferred
• 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)

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$192,200—$240,250 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease manage