Yale New Haven Health
Chief Molecular Development Scientist
Yale New Haven Health, New Haven, Connecticut, us, 06540
Overview: To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.
The Chief Development Scientist will supervise the development and implementation of complex clinical molecular assays in the disciplines of oncology and infectious disease. Working with the laboratory Medical Directors, Managers and Technologists, responsible for assay design, feasibility studies, clinical validation following all regulatory guidelines (CAP, CLIA, FDA, NY), and transference of assays to production. Additional responsibilities include optimization and troubleshooting of existing molecular methods, and the coordination and day to day supervision of the development staff. The Chief Development Scientist will be encouraged to attend conferences/meetings and provide educational activities such as talks and rotations for the technologists, medical residents, and fellows.
EEO/AA/Disability/Veteran Responsibilities:
Leads development activities including oversight of the development team as needed.
Review, analyze and interpret test results as needed.
Ensures that clinical data meets required quality metrics and assists with regulatory compliance according to CLIA, CAP, and State guidelines.
Works with medical directors concerning the needs and requirements for new clinical assays, methods and data analysis pipelines.
Works with medical directors to prioritize development efforts and allocates resources accordingly.
Reviews and approves assay validations prior to Medical Director review and implementation in clinical laboratory.
Provide technical support for both new and existing laboratory methods.
Provide technical supervision of lab procedures, including monitoring of appropriate test indication.
Provide educational talks and activities for technologists, med students, residents, and fellows.
Effectively communicates ideas, progress and data to laboratory staff, leadership and clinicians when appropriate.
Qualifications:
EDUCATION
Advanced degree in molecular genetics or similar biological sciences area of study. PhD preferred.
EXPERIENCE
Minimum of 5 years of experience in a clinical or research laboratory with a minimum of 3 years of proven experience in clinical molecular assay design, validation, and implementation according to CLIA and CAP guidelines. Experience in the development of molecular oncologic and infectious disease testing preferred. Knowledge of NY state regulations desirable.
SPECIAL SKILLS
Experience with Next Generation Sequencing Technologies, Bioinformatic pipelines, statistical methods/programs, and test method validation requirements required. Able to work independently and in a multidisciplinary team-based environment.
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The Chief Development Scientist will supervise the development and implementation of complex clinical molecular assays in the disciplines of oncology and infectious disease. Working with the laboratory Medical Directors, Managers and Technologists, responsible for assay design, feasibility studies, clinical validation following all regulatory guidelines (CAP, CLIA, FDA, NY), and transference of assays to production. Additional responsibilities include optimization and troubleshooting of existing molecular methods, and the coordination and day to day supervision of the development staff. The Chief Development Scientist will be encouraged to attend conferences/meetings and provide educational activities such as talks and rotations for the technologists, medical residents, and fellows.
EEO/AA/Disability/Veteran Responsibilities:
Leads development activities including oversight of the development team as needed.
Review, analyze and interpret test results as needed.
Ensures that clinical data meets required quality metrics and assists with regulatory compliance according to CLIA, CAP, and State guidelines.
Works with medical directors concerning the needs and requirements for new clinical assays, methods and data analysis pipelines.
Works with medical directors to prioritize development efforts and allocates resources accordingly.
Reviews and approves assay validations prior to Medical Director review and implementation in clinical laboratory.
Provide technical support for both new and existing laboratory methods.
Provide technical supervision of lab procedures, including monitoring of appropriate test indication.
Provide educational talks and activities for technologists, med students, residents, and fellows.
Effectively communicates ideas, progress and data to laboratory staff, leadership and clinicians when appropriate.
Qualifications:
EDUCATION
Advanced degree in molecular genetics or similar biological sciences area of study. PhD preferred.
EXPERIENCE
Minimum of 5 years of experience in a clinical or research laboratory with a minimum of 3 years of proven experience in clinical molecular assay design, validation, and implementation according to CLIA and CAP guidelines. Experience in the development of molecular oncologic and infectious disease testing preferred. Knowledge of NY state regulations desirable.
SPECIAL SKILLS
Experience with Next Generation Sequencing Technologies, Bioinformatic pipelines, statistical methods/programs, and test method validation requirements required. Able to work independently and in a multidisciplinary team-based environment.
#J-18808-Ljbffr