Director, R&D - Assay Development

Hims & Hers • South Plainfield, NJ

1d • Onsite

About The Position

Hims & Hers is seeking a Director of Research & Development to lead assay development and innovation efforts for our laboratory and diagnostics portfolio. This leader will be responsible for the development, optimization, validation, and implementation of diagnostic assays supporting both traditional and at home testing programs. This is a highly hands on leadership role. As an early R&D hire in New Jersey, the Director will build and lead the R&D function while also directly executing bench work, data analysis, and validation activities. The ideal candidate brings deep experience in assay development within a CAP/CLIA laboratory environment, strong statistical capabilities, and expertise working with high throughput clinical chemistry and hematology instrumentation. This is an on-site laboratory role based in Central New Jersey.

Requirements

• PhD in Clinical Chemistry, Biochemistry, Molecular Biology, Immunology, Biomedical Sciences, or related field
• Minimum 5 years of experience in diagnostic assay development within a clinical laboratory environment
• Demonstrated experience leading R&D initiatives and managing complex projects
• Experience with Roche Cobas Pro and Sysmex instrumentation
• Strong statistical knowledge, including method validation, experimental design, and data analysis
• Experience developing assays using blood specimens
• Proven ability to operate both strategically and tactically in a hands on lab environment

Nice To Haves

• Experience working with at-home diagnostic testing programs
• Experience validating assays using capillary blood collected via microtainers and devices such as Tasso or YourBio Health
• Experience in CAP and CLIA regulated laboratories
• Familiarity with FDA regulatory landscape for diagnostics and laboratory developed tests
• Experience building and scaling R&D teams

Responsibilities

• Scientific and Technical Leadership Lead development, optimization, and validation of new and existing diagnostic assays across the Hims & Hers testing portfolio
• Design and execute verification and validation studies in alignment with CAP and CLIA requirements
• Analyze and interpret experimental data, including statistical evaluation of method performance, precision, accuracy, linearity, and stability
• Develop validation protocols, reports, SOPs, and technical documentation
• Partner cross functionally to transition assays from R&D into clinical operations
• Instrumentation and Assay Development Lead assay development activities utilizing Roche Cobas Pro and Sysmex platforms initially with planned expansion into other technologies, including molecular, genetic, and infectious disease
• Support integration and performance evaluation of automated chemistry and hematology systems
• Develop and validate workflows involving capillary blood collected via microtainers and devices such as Tasso and YourBio Health
• Evaluate performance characteristics of capillary versus venous specimens where applicable, and investigate novel methods to expand stability of at-home collected samples
• Team Building and Organizational Development Hire, mentor, and develop a high performing R&D team, including scientists and research associates
• Establish R&D priorities, project timelines, and resource allocation plans
• Foster a culture of scientific rigor, operational excellence, and continuous improvement
• Serve as technical leader and subject matter expert across the diagnostics organization
• Hands On Execution Perform bench laboratory work as needed, particularly during early team build out
• Conduct statistical analysis and data review directly
• Troubleshoot assays, instrumentation, and workflow challenges
• Regulatory and Quality Collaboration Partner with Regulatory Affairs and Quality to ensure compliance with CAP, CLIA, and applicable state and federal requirements
• Support preparation for inspections and audits
• Maintain awareness of evolving regulatory requirements impacting laboratory developed tests and at home diagnostics

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree