Job description
POSITION SUMMARY:
Natera is seeking a highly experienced and strategic Senior Director of Product Development to lead the development and regulatory submission of our innovative early cancer detection products. This individual will be responsible for overseeing all aspects of product development, from research and feasibility exit to submission and post-market support, assisting with regulatory strategy and clinical validation. The Senior Director will work cross-functionally with varied teams needed to create an IVD ecosystem ensuring multiple successful product approvals and launches for a portfolio of devices.
PRIMARY RESPONSIBILITIES:
- Product Development Leadership: Drive development, design verification and validation of an innovative early cancer detection device using NGS and alternative analytes, ensuring compliance with FDA Class III NGS diagnostic device regulations.
- Regulatory Strategy & FDA Submission: Lead a team to create the performance data package needed for the preparation and submission of a Class III PMA application, working closely with regulatory affairs to develop a comprehensive approval strategy and interacting as a subject matter expert in correspondence and meetings with the FDA.
- Clinical Validation: Collaborate with clinical and regulatory teams to design and execute clinical validation studies that meet FDA and global regulatory requirements for submissions.
- Cross-Functional Team Leadership: Work collaboratively with research, bioinformatics, biostatistics, software engineering, clinical, regulatory quality, and commercial teams to align development efforts with business goals.
- Quality & Compliance: Ensure product development follows Natera’s QMS and all applicable guidance (ISO 13485, FDA QSR, etc), to meet regulatory and safety standards.
- Risk Management & Mitigation: Identify potential risks in the development and regulatory process and implement strategies to mitigate them.
QUALIFICATIONS:
- Education: Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field.
- Experience: Minimum 10+ years of experience in diagnostic device development, with a strong focus on Class III PMA-level submissions.
- Technical skills: Required prior experience with complex NGS-based diagnostic devices, with proven ability to understand and then translate the requirements of device development to other technical and non-technical teams to enable outstanding development processes and performance study designs.
- Regulatory Expertise: Proven track record of leading FDA Class III PMA or ex-US PMA submissions for novel diagnostic technologies and leading roll in interactions with regulatory agencies.
- Experience in liquid biopsy, molecular diagnostics in oncology applications.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Knowledge of Standards & Regulations: Deep knowledge of FDA regulations, ISO 13485, QSR, IVDR, and other applicable standards.
- Clinical & Scientific Background: Strong understanding of oncology diagnostics, design-controlled product development, and clinical validation.
- Leadership: Demonstrated experience in leading cross-functional teams, managing complex projects, and driving regulatory strategies.
- Strong Communication & Strategic Thinking: Ability to articulate complex regulatory and technical strategies to internal and external stakeholders to surface and drive decisions based on business and product requirements.
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
$255,600—$319,450 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 management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, 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!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
