Sr Director of IVD and Assay Validation

Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development.

Predicine has developed an international business utilizing its innovative liquid biopsy technology and molecular insights to empower biopharma partners in clinical drug development and expand opportunities around new oncology medicines. Fully recognized by global industry leaders, we are partnering with a slate of top 10 MNC BioPharmas to support biomarker-driven clinical trials in US, EU, APAC including China.

At Predicine, we believe people are our most important asset and we are dedicated to creating a great place to work. We value a culture of Integrity, Innovation, Quality, Respect, Courage, Collaboration, Caring, and Communication.

We invite people who share the same values to join us!

The Head (Sr. Director or VP) of In Vitro Diagnostic (IVD) and Assay Validation reports to the CEO and is responsible for the planning, execution, and operation of the company’s IVD Assay Validation for companion diagnostic (CDx), CLIA/CAP, and other assay and lab validations required for regulatory submissions. The head of In Vitro Diagnostic (IVD) and Assay Validation carries out duties for all aspects related to the analytical validation (AV) of CDx.

What you will get to do:

• Leads and manages the planning, operation, and execution of all processes involved in AV and IVD lab validation for CDx and other related studies.
• Designs the AV and other IVD-related studies and develops the AV study protocol(s).
• Plans for sample procurement.
• Writes the AV study reports for Premarket Approval (PMA) submission.
• Performs and leads the following, but not limited to:

1. Orthogonal Concordance (Accuracy)
2. LOB (Limit of Blank)
3. LOD (Limit of Detection)
4. Interfering Substances
5. Precision (repeatability and reproducibility)
6. Cross-contamination/carry-over
7. Guard banding
8. Reagent Interchangeability
9. Stability test
10. General lab equipment and reagent evaluation
11. Contrived Sample Functional Characteristic

• Builds a strong AV and IVD team.
• Manages and collaborates with CRO or partner companies for study operation.
• Responsible for communications with vendors and other internal functions.
• Supports lab work and applications to appropriate regulatory agencies (i.e., Breakthrough Device Designation and PMA).
• Manages study budget, expenses, and other financial aspects related to lab and clinical studies.
• Supports an audit from sponsors or regulatory agencies for clinical studies.
• Manages data collection, transfer, and storage based on the company policy.
• Cooperates with the internal Quality and Regulatory team for any issues related to AV study execution and operation.

Qualifications/Skills/Experience

• Bachelor’s degree in biology or a healthcare field. An advanced degree (i.e., Ph.D.) is preferred.
• Must have experience in AV study design, execution, report preparation, submission, and approval for CDx PMA. Should have good understanding of basic statistical analysis and hire or work with statistician(s)
• More than 15 years of experience in IVD and Assay Validation is required.
• Experience in liquid biopsy testing or next-generation sequencing (NGS) is desirable.
• Diagnostic IVD experience is required.
• CRO management experience is preferred.
• Experience with ISO 13485 and FDA medical device or IVD regulations is desirable.
• Experience and understanding of GCP, GCLP, and other clinical study-related regulations and guidelines are preferred.
• Excellent communication and interpersonal skills.
• Proven strong problem-solving ability and root cause analysis skills.
• Meticulous approach with close attention to detail.
• Competency in interpersonal skills within a diverse workforce. Written and verbal skills must be excellent.

Training:

• Additional training may be required based on job responsibilities and Competence, Awareness and Training procedure.
• HIPAA and other required trainings are required.

We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work.

Predicine is proud to be an equal opportunity employer committed to hiring a diverse and inclusive workforce. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.