Director, R&D - Assay Development

Responsibilities

• Lead the development, optimization, and validation of diagnostic assays for the laboratory and diagnostics portfolio
• Design and execute verification and validation studies in alignment with CAP and CLIA requirements
• Analyze experimental data, including statistical evaluation of method performance, precision, accuracy, and stability
• Develop validation protocols, reports, SOPs, and technical documentation
• Utilize Roche Cobas Pro and Sysmex platforms to support assay development and instrumentation integration
• Hire, mentor, and develop a high-performing R&D team of scientists and research associates
• Perform hands-on bench laboratory work, data analysis, and troubleshooting during the early team build-out phase
• Partner with Regulatory and Quality teams to ensure compliance with all applicable laboratory standards

Requirements

• PhD in Clinical Chemistry, Biochemistry, Molecular Biology, Immunology, Biomedical Sciences, or a related field
• Minimum 5 years of experience in diagnostic assay development within a clinical laboratory environment
• Proven experience with Roche Cobas Pro and Sysmex instrumentation
• Strong statistical knowledge, including expertise in method validation and experimental design
• Experience developing assays using blood specimens
• Ability to operate both strategically and tactically in a hands-on laboratory setting

Preferred Qualifications

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

Benefits

• Competitive salary and equity compensation
• 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 with employer matching contribution
• Offsite team retreats

About the Company

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery.