Director, Clinical Development

Baylor Genetics; United States; Hybrid; USD 230,000 - 320,000; Full time

Job summary

Baylor Genetics is seeking a Director, Clinical Development to provide scientific and clinical leadership for scalable genomic solutions. You will translate clinical needs into standardized workflows and automation-ready processes that improve quality and impact across the organization.

Responsibilities include leading portfolio initiatives from concept to post-launch, governing clinical workflow development, and collaborating with multiple teams to demonstrate clinical utility and value of

Qualifications

• Ph.D. or M.S. in genetics, genomics, molecular biology, clinical laboratory science, bioinformatics, or a related field.
• 12 years of relevant experience in clinical genomics or related field.
• Demonstrated expertise in genomic data interpretation, gene-disease/variant curation, clinical reporting, and development/validation of clinical laboratory workflows.
• Experience leading cross-functional development initiatives from requirements definition through validation, implementation, and performance monitoring.

Responsibilities

• Lead the Clinical Development portfolio from concept through pilot, validation, implementation, and post-launch evaluation with clear milestones and measurable outcomes.
• Provide clinical governance for genomic workflow development including quality gates and final clinical approval of development outputs.
• Direct development of structured clinical knowledge assets and reusable reporting content.
• Guide design and validation of automation and decision-support solutions for clinical review and reporting.
• Collaborate with internal and external teams to translate clinical requirements into executable deliverables.
• Design and execute evidence-generation initiatives to demonstrate product value and clinical utility of genetic testing services.

Skills

Genomics expertise

Clinical data interpretation

Project leadership

Cross-functional collaboration

Education

Ph.D. or M.S. in genetics or related field

Job description

The Director, Clinical Development provides scientific and clinical leadership for the development, validation, and implementation of scalable clinical genomics solutions. This role translates clinical needs and emerging genomic knowledge into standardized workflows, decision-support methods, knowledge assets, and automation-ready processes that improve quality, efficiency, and clinical impact across Baylor Genetics. The scope of this role may evolve as organizational needs and the Clinical Development portfolio change.

KEY RESPONSIBILITIES

• Lead the Clinical Development portfolio from concept through pilot, validation, implementation, and post-launch evaluation, establishing clear scope, milestones, acceptance criteria, risks, and measurable outcomes for each initiative.
• Provide clinical governance for genomic workflow development, including scientific standards, risk boundaries, quality gates, escalation criteria, and final clinical approval of development outputs before production use.
• Direct development of structured clinical knowledge assets, including gene-disease relationships, phenotype frameworks, variant interpretation, and reusable reporting content.
• Guide design and validation of automation and decision-support solutions for clinical review and reporting.
• Partner with Genomic Technology, Bioinformatics, Assay Development, Laboratory Operations, Quality Management, Regulatory, Medical Affairs, Product, and Commercial teams to convert clinical requirements into executable technical and operational deliverables.
• Collaborate with internal and external clinical experts to design and execute evidence-generation initiatives that demonstrate product value, support market access, and establish the clinical utility of genetic testing services.
• Coach, and develop senior scientists, and scientists assigned to project-based work; clarify decision rights, ensure effective resource deployment, and maintain accountability for high-quality, timely deliverables.
• Perform other duties as assigned to support team and organizational objectives.

QUALIFICATIONS

Required

• Ph.D. or M.S. in genetics, genomics, molecular biology, clinical laboratory science, bioinformatics, or a related chemical, physical, or biological science field.
• 12 years of relevant experience in clinical genomics, molecular diagnostics, clinical laboratory development, translational genomics, or a related field.
• Demonstrated expertise in genomic data interpretation, gene-disease and variant curation, clinical reporting, and development or validation of clinical laboratory workflows.
• Demonstrated experience leading cross-functional development initiatives from requirements definition through validation, implementation, and performance monitoring.
• Working knowledge of applicable clinical laboratory quality and regulatory requirements, including CLIA, CAP, and state requirements, as relevant to assigned responsibilities.
• Ability to communicate complex clinical and technical concepts clearly to scientific, operational, technology, quality, and executive stakeholders.
• Equivalent combination of education and experience may be considered where permitted by regulatory and business requirements.

Preferred

• Experience with whole-genome or whole-exome sequencing, automation-enabled clinical review, clinical decision support, artificial intelligence, or knowledgebase development.
• Experience managing multidisciplinary scientific teams and a portfolio of concurrent clinical development projects.
• Peer-reviewed publications, professional presentations, or other evidence of recognized expertise in clinical genomics or molecular diagnostics.

COMPETENCIES

• Clinical and scientific judgment
• Cross-functional influence and communication
• Data-driven validation and risk management
• Team development and execution accountability

PHYSICAL DEMANDS AND WORK ENVIRONMENT

• Location: Hybrid or remote, based on business needs and company policy.
• Work is primarily performed in an office or remote-work environment using a computer and standard office equipment.
• Must be able to communicate effectively through virtual and in-person meetings and review detailed scientific and clinical information for extended periods.
• Occasional access to a clinical laboratory environment may be required; applicable safety, training, and personal protective equipment requirements must be followed.
• Occasional travel may be required for company meetings, partner engagements, inspections, or scientific conferences.

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. If you need an accommodation during the application process, please contact our Human Resources team.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.