Baylor Genetics

• Lead end-to-end Epic Aura implementations • Develop and manage detailed project plans and timelines • Serve as the primary point of contact for clients throughout the implementation lifecycle • Collaborate with engineering and integration teams to design and deploy Epic Aura integrations • Monitor system performance and user feedback for continuous optimization

Role Description - Lead the planning, design, and execution of analytical validation studies for sequencing-based assays, including germline, somatic, and liquid biopsy applications. - Develop and maintain validation strategies, protocols, and reports that comply with CLIA, CAP, NYS, and internal quality standards. - Collaborate with Assay Development, Bioinformatics, Quality, and Product teams to align validation strategy with assay design, clinical claims, and product readiness. - Establish acceptance criteria, reference materials, and performance metrics to support analytical and clinical validation activities. - Serve as the subject matter expert for NGS validation methods, study design, assay performance characterization, and regulatory expectations. - Analyze validation data and provide data-driven recommendations for assay optimization, issue resolution, and launch readiness. - Support regulatory or laboratory inspections and contribute to responses, documentation, or corrective action plans as needed. - Mentor scientists at different levels and contribute to building a scalable validation function within the R&D organization. - Maintain up-to-date knowledge of emerging trends, technologies, and regulatory guidance in NGS assay validation and clinical genomics. - Perform other duties as assigned to support team and organizational objectives. - Comply with all company policies, procedures, and applicable regulatory requirements. Qualifications - PhD. in Molecular Biology, Genetics, Genomics, or a related discipline with 6+ years of relevant experience; or M.S. with 8+ years of experience in NGS assay development and validation. - Demonstrated track record leading validation of clinical NGS assays under CLIA, CAP, NYS, or equivalent regulatory frameworks. - Strong expertise in NGS library preparation, sequencing platforms, and assay performance characterization. - Deep understanding of analytical validation parameters, including accuracy, precision, limit of detection, specificity, reproducibility, and related statistical evaluation. - Experience collaborating with bioinformatics teams for pipeline verification and integrated assay validation. - Familiarity with quality management systems, design control, and documentation best practices. - Excellent problem-solving, communication, and cross-functional collaboration skills. - Proven ability to lead complex projects and influence without direct authority in a matrixed environment. - Equivalent combination of education and experience may be considered. Requirements - Prior experience with germline clinical genetic testing or prenatal liquid biopsy testing. - Knowledge of NYS clinical test submission requirements or FDA IVD development processes. - Experience managing a small team. - Familiarity with automation or process scaling for NGS workflows. Competencies - Scientific rigor and strong attention to detail. - Strategic thinking with hands-on execution capability. - Collaborative mindset with strong communication across scientific and business functions. - Commitment to quality, compliance, and continuous improvement. Physical Demands and Work Environment - Location: Houston, TX / Remote. - Work may be performed in an office, remote, and/or laboratory environment depending on business needs and assigned responsibilities. - May require exposure to standard laboratory conditions and adherence to applicable safety, quality, and regulatory requirements. - Must be able to use standard office equipment and computer systems for extended periods. - Travel requirements may vary based on business needs. EEO Statement Baylor Genetics is proud to be an equal opportunity employer committed to fostering an inclusive and diverse workplace. We welcome and encourage applicants from all backgrounds to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, pregnancy, childbirth, or any other status protected by applicable federal, state, or local law.

• Develop a strategic and comprehensive privacy program in alignment with regulatory standards • Establish and enforce policies ensuring the confidentiality of protected health information (PHI) • Manage privacy-related committees and initiatives in coordination with the Vice President and General Counsel and Director of Audit • Provide leadership in training and educating the workforce on privacy matters • Collaborate with IT Security and Information Services to integrate privacy and security programs • Develop and maintain metrics and reports to assess privacy compliance and risk analysis • Monitor compliance activities and assess privacy concerns in coordination with other compliance functions • Oversee compliance of business associates and business associate agreements related to privacy • Manage the process for receiving, investigating, and addressing privacy-related complaints • Ensure timely compliance with breach notifications as per HIPAA and state laws • Conduct information privacy awareness activities and provide training to Baylor Genetics teams • Work on litigation and administrative matters related to privacy issues in coordination with legal counsel • Supervise the Regulatory and Compliance Manager, assigning duties as necessary • Develop strategies to ensure compliance with various regulations like GDPR, FERPA, PCI, among others

• Develop and execute a regional sales plan to meet or exceed sales targets. • Identify and pursue new business opportunities within assigned territory. • Establish and maintain strong relationships with healthcare providers, hospitals, and key decision-makers. • Present and promote company products and services to prospective clients. • Collaborate with marketing, operations, and support teams to deliver tailored client solutions. • Track and manage sales pipeline, forecasts, and territory activity using CRM tools. • Attend industry conferences, trade shows, and networking events to increase brand visibility. • Stay informed on industry trends, competitor activities, and customer feedback to drive strategy. • Provide regular reports on account status, opportunities, and performance metrics to leadership. • Perform other duties as assigned to support team and organizational objectives.

• Design and perform specific experiments in support of R&D projects in NGS, Molecular, Cytogenetics or Biochemical Genetics platforms. • Work with clinical team to validate and transfer tests to clinical diagnostic workflows. • Work with Product Development Team to plan and execute R&D strategies. • Assist with laboratory training and education of external team. • Develop Standard Operating Procedures (SOPs). • Perform clinical tests as needed after proper training. • Prepare validation materials for review in adherence to regulatory agencies and requirements. • Conduct routine lab duties as assigned by supervisor, manager, or lab director.

• Reviewing test requisition forms and clinical notes, extracting clinical information into structured data, such as HPO terms • As needed, opportunities for cross-training in WGS variant curations or WGS report writing may become available

• Review test requisition forms and clinical notes • Perform case analysis using the Emedgene platform • Identify and select variants relevant to the proband’s phenotype • Request confirmatory testing when necessary • Communicate findings at cross-team huddles • Opportunities for cross-training in WGS variant curations or clinical indication may become available as needed

• Complete Initial Credentialing & Re-Credentialing applications to gain in-network status with commercial payors & Managed Medicaid payors • Manage and track application submissions via Salesforce • Perform timely follow-ups with payers • Collaborate closely with Market Access Team to gather necessary information and documents for network expansion initiatives • Serve as point person for assigned payers to resolve application and enrollment issues • Monitor expiration dates for assigned payers and enrollments to ensure timely renewal and prevent lapses in participation • Ensure compliance with payer specific requirements and state/federal regulations

• Post payments accurately and promptly from various sources including clients, insurance companies, and patients. • Collaborate with the accounting team to ensure batches are posted correctly and that all unapplied cash is accounted for. • Track daily cash sheets and save ACH transaction details, copies of checks, and payment advice. • Ensure accurate reconciliation of accounts to balance at the end of each month. • Obtain addenda information from Bank of America and payment advice from clients and payors. • Post and manage ERA files efficiently and understand how to interpret Explanation of Benefits. • Coordinate with the accounting team regularly to ensure monthly financial balancing and resolve any discrepancies immediately. • Assist in developing and implementing processes that improve and streamline financial procedures. • Perform other duties assigned by the Associate Director of Billing and Senior Director of Revenue Cycle and Optimization

• Accurately input and process data from various sources into company systems, databases, and spreadsheets. • Review and verify test data for accuracy and completeness. • Perform regular data audits to ensure data integrity. • Identify and resolve discrepancies, working with internal departments as needed. • Provide feedback about processes and roadblocks.