VP, R&D, Molecular Assay Development

Bio-Rad Laboratories, Inc; Hercules (CA); On-site; USD 278,000 - 400,000; Full time

Benefits offered by this job

Relocation assistance

Total Rewards Program

Comprehensive benefits

Job summary

Bio-Rad Laboratories, Inc. in Hercules, CA is seeking a senior leader to head Global Assay Development within the Clinical Diagnostics Group. You will set multi-modality portfolio strategy and guide molecular assay programs from concept through transfer, ensuring FDA/IVDR/CE readiness and audits.

You will own the operating plan, budget, and talent strategy, manage Sr. Directors, and align quality, regulatory, and supply chains.

Qualifications

• 12+ years of progressive leadership in IVD/diagnostics R&D with assay leadership.
• Deep knowledge of regulated development and quality systems (FDA QSR/ISO 13485, IVDR/CE).
• Expert-level molecular assay chemistries and workflows (qPCR, dPCR, NGS).

Responsibilities

• Set strategic direction and multi-year investment for Global Assay Development.
• Own phase-gate governance, development standards, and performance thresholds.
• Serve as R&D sponsor for design-control governance and major submissions/audits.
• Define technology strategy across modalities and manage make/buy/partner decisions.
• Own operating plan, budget, and talent strategy; lead Sr. Directors and executives.
• Align with Quality, Regulatory, Supply Chain, and Commercial leadership.

Skills

Strategic leadership

Executive communication

Global cross-functional leadership

Portfolio governance

Education

Master’s degree in Chemistry/Biochemistry/Molecular Biology/Bioengineering

Ph.D. in Chemistry/Biochemistry/Molecular Biology/Bioengineering

Job description

Leads the Global Assay Development organization (US/EU) within Bio-Rad's Clinical Diagnostics Group, setting multi- modality portfolio strategy and translating it into robust, scalable IVD assays—with particular depth in molecular (PCR, real-time PCR, digital PCR, and sequencing-based) diagnostics. Owns assay development governance (phase-gate, metrics, and risk reviews) at the portfolio level and is the final escalation point for technical, quality, regulatory, and supply constraints that cross platform or functional lines. Owns the organization's operating plan, budget, and talent strategy, directly managing and developing Sr. Directors, and represents Global Assay Development to Quality/Regulatory and executive leadership on design control strategy supporting FDA/IVDR/CE submissions and audits.

How You’ll Make an Impact:

• Set the strategic direction and multi-year investment strategy for the Global Assay Development organization across all assay modalities — with particular depth in molecular (PCR, real-time PCR, digital PCR, and sequencing-based) diagnostics — partnering with Business Unit leaders, Marketing, and Finance to commit R&D investment against growth, margin, and menu-expansion targets.
• Own the phase-gate governance framework, org-wide development standards, and analytical/clinical performance bar across all assay modalities, setting the go/no-go criteria and quality thresholds that Sr. Directors and Directors execute against.
• Serve as the R&D executive sponsor for design-control governance, representing Global Assay Development to Quality/Regulatory leadership and to FDA/IVDR/CE auditors and inspectors on major submissions and inspections.
• Set the multi-year technology strategy for emerging assay science across all modalities, deciding where the organization builds proprietary capability versus partners, licenses, or acquires — approving major make/buy/partner and licensing decisions and leading executive-level technical due diligence with Legal/Corporate Development.
• Own the organization's operating plan, budget, and talent strategy; build and scale world-class technical leadership across all modalities, and personally engage on the highest-risk, highest-visibility technical and clinical-readiness decisions that carry portfolio-wide or company-level risk.
• Hold peer-level accountability with Systems/Instrument R&D, Manufacturing, Supply Chain, Clinical, Quality, Regulatory, and Commercial leadership to align the integrated systems roadmap, resolving conflicts that Sr. Directors cannot resolve at the program level.
• Represent Global Assay Development to the CDG executive team and Bio-Rad leadership, owning the narrative on portfolio health, investment tradeoffs, and risk, and defending resourcing decisions at the executive level.
• Own competitive and scientific intelligence for the assay portfolio, translating industry, scientific, and IVD-market trends into executive-level recommendations on where to invest, divest, or accelerate.
• Set relative investment priority and resource allocation across assay modalities (molecular, immunoassay, clinical chemistry, and other platforms) within the Global Assay Development portfolio, balancing growth, margin, and menu expansion goals org-wide.

What You Bring:

• Education: Master’s degree or Ph.D. in Chemistry, Biochemistry, Molecular Biology, Bioengineering, or a related discipline (required).
• Work Experience: 12+ years of progressive leadership in IVD/diagnostics R&D, including significant experience leading assay/reagent development organizations, with particular depth in molecular (PCR, digital PCR, isothermal, or sequencing-based) platforms (required).
• Demonstrated track record delivering molecular assays (PCR-based, digital PCR, or sequencing-based) from concept through transfer, including design inputs/outputs, verification/validation, and launch readiness (required).
• Deep knowledge of regulated development and quality systems (FDA QSR/ISO 13485, IVDR/CE), with a strong inspection/audit readiness mindset (expert level).
• Deep technical fluency in molecular assay chemistries and workflows (qPCR/dPCR, multiplex PCR, isothermal amplification, NGS library prep, and nucleic acid extraction), sufficient to make informed organization-wide technical strategy and risk decisions (expert level).
• Proven ability to lead globally distributed, cross-functional teams and influence at the executive level; strong strategic, communication, and talent-development skills (expert level).
• Assay development governance, standards-setting, and design-control strategy, including phase-gate planning, metrics, risk reviews, and compliance strategy across a global, multi-modality program portfolio (expert level).
• Technology and portfolio strategy, including evaluation and maturation of enabling technologies, build/buy/partner/licensing decision-making, and external partnerships across all assay modalities (expert level).
• Business acumen, including multi-year investment strategy and P&L trade-off analysis across a global, multi-modality organization (expert level).

Location:

This position must be based in Hercules, CA and requires the employee to be located within commuting distance of the office.

Relocation Assistance:

Relocation assistance may be available for candidates who require relocation for this position, in accordance with company policy and business needs.

Total Rewards Package:

At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

Benefits:

We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!

Compensation:

The estimated base salary range for this position is $278,000 to $400,000 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

Who We Are:

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement:

Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.