Senior Director, Product Development

Natera, Inc.; San Carlos (CA); Remote; USD 255,000 - 320,000; Full time

Job summary

An established industry player is seeking a Senior Director of Product Development to spearhead the creation of groundbreaking early cancer detection products. This strategic role encompasses overseeing the entire product development lifecycle, from initial research to regulatory submission, ensuring compliance with stringent FDA regulations. The ideal candidate will leverage their extensive experience in diagnostic device development and regulatory strategy to lead cross-functional teams towards successful product launches. Join a forward-thinking organization that is committed to innovation and excellence in oncology diagnostics, and make a significant impact on patient outcomes through cutting-edge technology.

Qualifications

• 10+ years in diagnostic device development focused on Class III PMA submissions.
• Advanced degree in Molecular Biology or Biomedical Engineering required.

Responsibilities

• Lead development and regulatory submission for early cancer detection products.
• Collaborate with teams to ensure compliance with FDA regulations.

Skills

Regulatory Strategy

Product Development

Clinical Validation

Cross-Functional Leadership

Risk Management

Communication Skills

Education

PhD in Molecular Biology

MD or equivalent in Life Sciences

Tools

NGS Technology

ISO 13485 Standards

Job description

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.

Remote USA

$255,600 - $319,450 USD