Chief Scientific Officer

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.

1) Scientific Strategy & Portfolio Governance

1. Define the scientific vision and a multi‑year portfolio (platforms, assays, enabling technologies) with clear stage gates, risk mitigation, and ROI‑grounded resourcing.
2. Chair Portfolio Review and Scientific Advisory Board processes; set OKRs/KPIs for discovery, pre‑product de‑risking, clinical validation, and launch readiness.

2) Product & Platform Innovation (PCR, dPCR, NGS & beyond)

1. 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.
2. Ensure robust design inputs/outputs, verification/validation, and technology transfer to operations and clinical settings; steward IP strategy and external visibility (publications, patents, podium).

3) Clinical/Translational & Regulatory Interface

1. 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.
2. 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.

4) Computational Genomics, Data Integrity & Decision Science

1. Lead the bioinformatics vision: validated pipelines for PCR/dPCR/NGS (e.g., variant calling, transcriptomics, metagenomics), reproducible workflows, and secure, audit‑ready data management.
2. 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.

5) Biobank & Control/Reference Material Strategy

1. 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.
2. Anchor operations to international biobank standards and robust LIMS practices; align output with the needs of R&D, clinical validation, and commercial supply.

6) Research Excellence, Publishing Culture & Talent Development

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

7) External Partnerships & Ecosystem Leadership

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

12–18‑Month Success Outcomes

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

Required Qualifications

1. 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.
2. End‑to‑end assay/platform expertise across qPCR/multiplex PCR, dPCR, and NGS, including primer/probe design, workflow optimization, and clinical performance evaluation.
3. 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.
4. 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.
5. Experience establishing/overseeing biobank and control/reference material programs aligned to international standards and LIMS best practices.
6. Distinguished publication and IP record; history of mentoring senior scientists and fostering a high‑output research culture.

Preferred Qualifications

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