Director, R&D Scientific Services
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cepheid, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life.
At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world.
The Director, R&D Scientific Services, is responsible for enabling technical support critical technical linchpin between Innovation and Product Life Cycle R&D. This role provides specialized technical leadership for the R&D Pre-clinical and newly established Microbiology/Biorepository teams, ensuring the on-time delivery of the high-priority Innovation, New Product Development (NPD) and Sustainment pipeline. This position requires a rare intersection of Assay Development, Clinical Microbiology, and Scientific Validity expertise. You will manage the transition of complex assays into efficient, customer-facing workflows.
This position reports to the Senior Director of R&D Operations and is part of the R&D Platform & Services Organization located in Sunnyvale, CA and will be an on-site role.
In this role, you will have the opportunity to:
- Architect Strategic Roadmaps: Develop and execute the long?term strategy and roadmap for R&D Scientific Services, ensuring total alignment with R&D and broader business priorities.
- Scale Scientific Innovation: Translate emerging scientific and technological advances into scalable service capabilities that empower the R&D organization.
- Drive R&D Pre-Clinical Excellence: Lead the execution of clinical trial readiness in alignment with analytical study deliverables to ensure seamless product development phase transitions.
- Master Site Management: Lead site initiations and staff training for field studies, ensuring scientific validity across all external touchpoints.
- Ensure Analytical Rigor: Provide data oversight for panel preparation and prototype design iterations to accelerate feasibility cycles.
- Synchronize Cross-Functional Workflows: Serve as key collaboration driver between R&D, Scientific/Medical Affairs, Clinical Affairs and Regulatory/Quality to eliminate technical and operational bottlenecks.
- Modernize Microbiology Operations: Build and oversee the R&D Microbiology/Biorepository team, managing specimen and clinical matrix allocation and the development of external controls.
The essential requirements of the job include:
- Bachelor's degree with 14+ years of experience, or Master's/Doctoral degree with 12+ years of experience in microbiology and molecular biology laboratory work in hospital, public health or industry job.
- Leadership: Proven track record of managing high-performing scientific teams and creating long-term technical roadmaps.
- Regulatory & Quality: Deep understanding of analytical study requirements and quality and compliance rigor for clinical trial readiness protocols.
- Operational Agility: Demonstrated ability to manage high-stakes NPD pipelines and execute risk mitigation strategies for early-stage development.
- Technical Expertise: Direct experience in Assay Development and Clinical Microbiology within an IVD or regulated biotechnology environment.
Physical/Environment Requirements:
- Ability to work in a BSL-2 laboratory environment, which requires Hepatitis B vaccination. If you are not vaccinated, Cepheid will provide authorization to receive the vaccination series at no expense.
It would be a plus if you also possess previous experience in:
- Biostatistical Expertise: Experience in biostatistics as it relates to study design (e.g., sample size determination, power analysis) and clinical performance analysis for IVD products.
- Continuous Improvement: Experience with the Danaher Business System (DBS) or similar lean/Six Sigma frameworks to drive operational efficiency.
- Strategic Technical Planning: A history of translating complex scientific advances into scalable, customer-facing service capabilities.
- Advanced Diagnostics Knowledge: Familiarity with automated molecular diagnostic platforms and the integration of internal/external controls.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.