Director/ Sr. Director, Clinical Assay Development

La Jolla, CA

Our venture-backed, startup client in La Jolla, CA uses CRISPR to guide next generation cancer precision medicine. They are currently looking for a Director or Sr. Director of Clinical Assay Development to be responsible for leading the design, development, optimization, and validation of CRISPR assays critical for personalized medicine programs. They are looking for an experienced scientist with a proven track record in diagnostic assay development coupled with a high level of professional leadership ability. This individual will play a pivotal role in advancing their mission to deliver innovative products that improve patient care.

What You’ll Do:

• Lead a cross-functional team in the design, development, optimization, and validation of clinical diagnostic CRISPR assays for various projects.
• Partner with R&D, data science, clinical, and business development teams to design and deliver fully integrated sample-to-results workflows that meet product and operational requirements.
• Ensure complete, real-time project transparency for senior management to ensure alignment with company objectives.
• Collaborate with R&D and data science teams in study design, data exploration, and result interpretation.
• Ensure that assay development processes adhere to industry regulations and standards, including FDA requirements, CLIA standards and CAP policies or mandates.
• Implement rigorous validation and quality control procedures to ensure assay accuracy, precision, and reproducibility.

About You:

• Ph.D. in Molecular Biology, Biochemistry, Immunology, or relevant scientific disciplines.
• 10 years of experience in CLIA LDT and/or IVD assay development in the biotech or pharmaceutical industry.
• Proficient in managing multiple projects as part of a diverse cross-functional team with matrixed resources.
• Strong technical proficiency in molecular biology techniques including applications of CRISPR technology, cell-based assays, and immunoassays.
• Extensive scientific understanding of cancer biology and immunology.
• Excellent understanding of CAP, CLIA, and FDA regulatory requirements and quality control processes in the medical device/diagnostic setting.
• Strong verbal and written communication skills to be effective in communicating and interacting with a diverse group of people.
• Ability to work efficiently but with a high degree of precision.
• Able to work a flexible schedule with excellent time management skills, to ensure that work is completed on schedule.
• A mindset of ownership, urgency, focus and accountability

In addition to a competitive compensation package with stock options and a short-term incentive plan, our Client also offers a comprehensive benefits package for their employees and their families, which includes medical, dental, vision, life, disability and a 401(k) plan with an employer match.

The anticipated salary range for candidates who work in San Diego, CA is $200,000 to $240,000. The base salary compensation may vary outside of the anticipated range based on factors such as the type and length of experience within the job, type and length of experience within the industry, education, and other merit factors.