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Company

Bitscopic · 9 hours ago

Molecular Pathologist (PGx)

United States

Full-time

Remote

Senior Level

5+ years exp

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AnalyticsArtificial Intelligence (AI)

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Responsibilities

Clinical Report Review and Sign-Off

Provide final validation and sign-off for clinical pharmacogenomics reports

Ensure the accuracy, completeness and clinical relevance of interpretations derived from NGS data

Variant Analysis and Interpretation

Oversee and validate genotype, haplotype, and structural variant calls across custom biomarkers

Ensure interpretations adhere to standards such as CPIC (Clinical Pharmacogenetics Implementation Consortium, DPWG (Dutch Pharmacogenetics Working Group), and FDA guidelines

Regulatory Compliance

Maintain compliance with CLIA, CAP, and VA standards

Provide necessary documentation and sign-offs to meet regulatory and VA-specific requirements

Collaboration with Bioinformatics Teams

Work closely with bioinformatics teams and software development teams to implement robust PGx interpretation pipelines

Stay current with evolving PGx science and VA’s custom biomarker panels

Knowledgebase Management

Oversee and periodically review the clinical knowledgebase integrated within the PGx platform

Ensure it reflects up-to-date standards and provides actionable PGx insights.

Qualification

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Molecular PathologyPharmacogenomicsNGS InterpretationCLIA ComplianceCAP ComplianceFDA Regulatory KnowledgeIllumina PlatformThermoFisher PlatformClinical Report ReviewBioinformatics CollaborationClinical Informatics CertificationBioinformatics TrainingPythonR Programming

Required

MD/DO, with Pathology Residency/Fellowship training

FACMG Board certification in Molecular Genetic Pathology

Eligibility for credentialing as a high-complexity CLIA PGx Laboratory Director

Minimum of 5 years of experience in clinical molecular pathology with a focus on pharmacogenomics or genomic medicine

Proven experience in reviewing and signing off on clinical genomic reports

Proficiency in interpreting NGS-based pharmacogenomic data

Experience with platforms such as Illumina and ThermoFisher

Familiarity with regulatory standards for NGS informatics pipelines

In-depth knowledge of CLIA, CAP, and FDA regulatory requirements

Familiarity with regulatory standards for NGS informatics pipelines

Excellent communication skills

Experience working in cross-functional teams within healthcare or clinical laboratory settings

Preferred

Prior experience in pharmacogenomics projects within large healthcare organizations or federal healthcare systems, such as the Veterans Affairs (VA)

Additional certifications or training in clinical informatics, bioinformatics or related fields

A basic understanding and experience with the use of Python or R is potentially helpful for discussion with computer programmers building the pipeline