Director, R&D - Assay Development
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 putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.
Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.
About the Role:
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.
You Will:
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
You Have:
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
Preferred
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
Our Benefits (there are more but here are some highlights):
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
We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.
Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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