Job Details

Chief Scientific Officer (CSO)

The CSO leads a cross‑functional organization spanning R&D, translational/clinical validation, bioinformatics, biobank/control‑material programs, and scientific quality/regulatory interfaces—partnering tightly with Operations, Quality/Regulatory, Commercial, and Finance.

Science & Innovation Vision

• Define the scientific vision and a multi‑year portfolio (platforms, assays, enabling technologies) with clear stage gates, risk mitigation, and ROI‑grounded resourcing.
• Chair Portfolio Review and Scientific Advisory Board processes; set OKRs/KPIs for discovery, pre‑product de‑risking, clinical validation, and launch readiness.
• Direct concept‑to‑commercial development of molecular assays and enabling chemistries—qPCR/multiplex PCR, dPCR, NGS (targeted/gene panels, metagenomics/transcriptomics), and workflow innovations that raise sensitivity, specificity, throughput, and cost efficiency.
• Ensure robust design inputs/outputs, verification/validation, and technology transfer to operations and clinical settings; steward IP strategy and external visibility (publications, patents, podium).

Clinical/Translational & Regulatory Interface

• Oversee clinical readiness and collaborate with laboratory leadership to maintain impeccable compliance and inspection readiness; ensure method selection/validation, proficiency testing, and performance monitoring meet high‑complexity standards.
• Where appropriate, supervise or partner with site Laboratory Directors and Technical Supervisors; align scientific rigor with quality systems (e.g., ISO 13485, cGMP, 21 CFR Part 11) and the needs of FDA/IVD/IVDR pathways.

Computational Genomics, Data Integrity & Decision Science

• Lead the bioinformatics vision: validated pipelines for PCR/dPCR/NGS (e.g., variant calling, transcriptomics, metagenomics), reproducible workflows, and secure, audit‑ready data management.
• Embed HIPAA/GDPR‑aligned data governance and healthcare interoperability (e.g., HL7/FHIR) into product and clinical reporting; champion cloud/HPC and ML where they add measurable value.

Biobank & Control/Reference Material Strategy

• Establish/scale biospecimen and control‑material programs to underpin assay development and clinical deployment—covering collection, cryopreservation, chain‑of‑custody, stability programs, and large‑batch QC.
• Anchor operations to international biobank standards and robust LIMS practices; align output with the needs of R&D, clinical validation, and commercial supply.

Research Excellence, Publishing Culture & Talent Development

• Set the bar for scientific rigor, reproducibility, and publication impact; guide manuscript strategy, conference presence, and grant/consortium participation.
• Build and mentor a deep bench of scientific leaders; cultivate a lab culture that values documentation, peer review, and cross‑functional learning.

External Partnerships & Ecosystem Leadership

• Develop strategic collaborations with academic centers, healthcare systems, KOLs, and industry partners; represent with regulators, payers, and standards bodies.
• Support BD/investor dialogues and technical due diligence for partnerships, acquisitions, and novel platform evaluations.

Success Outcomes (12–18 Months)

• A resourced, staged scientific roadmap with 2–3 platform bets and 4–6 high‑value assay or product programs advancing through formal design control.
• Clinically grounded validation plans and traceable data packages supporting CLIA deployment and/or IVD pathways; zero‑major‑findings inspection posture maintained across sites.
• Production‑grade bioinformatics pipelines with documented version control, audit trails, and reporting frameworks integrated into wet‑lab workflows.
• Scaled biobank/control‑material capability with stability models and LIMS/QC dashboards informing assay performance.
• Visible external footprint—invited talks, senior‑author publications, and IP filings arising from assay/platform innovation.

Required Qualifications

• PhD or MD/PhD in Molecular Biology, Genetics, Biochemistry, Bioengineering, Computational Biology, or a closely related field; 15+ years of progressive scientific leadership with successful product commercialization in molecular diagnostics/omics.
• End‑to‑end assay/platform expertise across qPCR/multiplex PCR, dPCR, and NGS, including primer/probe design, workflow optimization, and clinical performance evaluation.
• Proven leadership of clinical/regulated environments (CLIA/CAP/COLA; ISO 13485; 21 CFR Part 11) and fluency in translating scientific evidence into submission‑ready validation packages; eligibility to serve as or supervise high‑complexity CLIA laboratory directorship is a strong plus.
• Track record of building validated computational pipelines and ensuring data integrity/security in clinical or near‑clinical contexts; facility with R/Python/UNIX environments via expert teams.
• Experience establishing/overseeing biobank and control/reference material programs aligned to international standards and LIMS best practices.
• Distinguished publication and IP record; history of mentoring senior scientists and fostering a high‑output research culture.

Preferred Qualifications

• Demonstrated success transferring technologies from R&D to clinical or commercial laboratories and supporting market launch.
• Exposure to IVDR/CE‑marking strategies and global regulatory interactions; familiarity with design risk management and post‑market performance monitoring.
• Experience integrating real‑world evidence, health‑economic considerations, and payer requirements into scientific plans.

Seniority Level

• Executive

Employment Type

• Full‑time

Job Function

• Management
• Industries: Research Services

Location

Tyler, TX