Associate Director, Research and Product Development (IVD)

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required.

POSITION SUMMARY:

The Associate Director, Research and Product Development (IVD) manages development of diagnostic assays/processes under Quality System Regulations and Design Control. Builds and manages a team to ensure product performance by employing proven development practices following IVD recommended guidelines and design approaches. Provides leadership in providing optimal strategy for product design, verification, validation, and bridging for regulatory submissions. Actively collaborates with Natera's technical, clinical, regulatory and quality assurance team and provides technical expertise to support corresponding IVD submissions to regulating organizations.

• Technical lead on IVD product development activities under a design control. Responsible for providing technical expertise and leadership in product design and development planning, experimental design, experimental execution, data analysis, specification verification, analytical validation and intended use clinical validation.
• Prepare overarching design documents, such as, design verification plans, reagent and product stability plans, design inputs, design outputs, etc.
• Ensure product performance by employing proven development practices - dFMEA, DOE, guardband testing, gauge R&R, stability/robustness testing, assessment of analytical performance, etc, following CLSI based design.
• Develop and implement quality control procedures for critical reagents and processes.
• Participate in discussions with pharma partners and act as R&D lead during such meetings.
• Supervises the activities of direct reports or team members and manages execution of studies to support verification and validation of assays.
• Ensures all verification and validation studies are conducted under Good Lab Practices and maintains documentation required to meet QSR Design Control and other international standards (e.g., ISO 13485, and IVDR requirements).
• Works closely with biostatistics/data science groups in aligning with rationale for study designs and acceptance criteria.
• Interacts with on-site CLIA lab, CDx operations team and other functional groups, such as, Research, Operations, Engineering and Software, among others, to find solutions and harmonize on timely deliverables.
• Performs basic data analysis (e.g. R, JMP, Excel).
• Communicates progress directly with colleagues and senior management.
• The employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.
• The employee must pass a post-offer criminal background check.

• Ph.D. with a minimum of 8 years of industry experience.
• 5+ years of management experience required.
• Prior experience in IVD product development required.
• Prior experience in managing R&D teams

• Track record of developing diagnostic tests or reagent kits in a regulated environment is required.
• Knowledge of quality and regulatory requirements (ISO 13485, 21 CFR Part 820, Risk Analysis ISO 14971) is highly desired.
• Hands on experience with Next Generation Sequencing on Illumina platforms is highly desired.
• Mastery of qPCR/multiplex PCR/hybrid capture - primer design, master mix formulation, protocol optimization; fundamental expertise in nucleic acid quantitation and fragment analysis is required.
• Experience assembling 510(k) and/or PMA documentation is a plus.
• Experience developing tests in oncology, NIPT or liquid biopsy a plus.
• Very strong analytical and problem-solving skills; organized and efficient
• Proven interpersonal, communication, and presentation skills; excellent time management skills
• Superb attention to detail; produces work of exceptional quality and accuracy
• Ability to thrive in a fast-paced, evolving environment; able to manage competing priorities
• Ability to proactively identify issues and address with solutions-oriented approach