Senior Manager, Precision Medicine CLIA Operations Job at Labcorp Drug Development - USA
Labcorp is a leading healthcare company that provides a range of diagnostic and medical laboratory services to patients, healthcare providers, and biopharmaceutical companies. With annual revenue of over $10+ billion and more than 70,000 employees, Labcorp is a recognized leader in the healthcare industry.
Essential Duties and Responsibilities:
Education and/or Work Experience Requirements:
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement .
Essential Duties and Responsibilities:
- Manages a team of scientists and/or technologists to contribute to the late-stage development of technologies for research and clinical use.
- Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and services.
- Ensure compliance with clinical laboratory accreditation agency (CAP and ISO 15189) requirements and terms of accreditation, including participation in required inspections, audits and self-inspections.
- Support assay validation/verification and optimization, as well as ongoing proficiency testing, alternative assessment and quality control procedures.
- Work with the leadership team to review project budgets and resources to ensure they are in line with objectives.
- Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.
- Develop and promote necessary operational performance levels aligned to regulatory requirements and corporate goals and objectives for both PGDx and OmniSeq as part of the Labcorp enterprise.
- Provide clinical expertise for corporate initiatives to modify existing tests, expand new testing capabilities. This includes involvement in the selection and monitoring of laboratory equipment, supplies and services, as well as the selection and monitoring of laboratory suppliers and referral laboratories.
- Collaborates with functional areas, including laboratory operations, bioinformatics, and analysis for the successful development of research and clinical use technologies.
- Makes significant contributions to the scientific direction of the company including initiation of research that may lead to major new programs.
- Maintains broad knowledge of state-of-the-art principles and theory.
- Makes important contributions to scientific literature and conferences.
- Applies and/or develops highly advanced technologies, scientific principles, theories and concepts that may be new to the industry.
- Plans and carries out focused experimental programs and analyses to evaluate the sensitivity, robustness, scalability, and other relevant characteristics of emergent genomic and allied technologies for regulatory approval processes.
- Works collaboratively with vendors, partners, and colleagues as part of a comprehensive technology evaluation strategy.
- Helps author detailed, accurate, and accessible procedural protocols and records.
- Facilitates transition of select technologies to operations scale-up and platform teams; serve as an ongoing knowledge resource for these technologies.
- Establishes and maintains procedures for maintaining standards and consistency in R&D operations.
- Promotes quality and procedural improvement thought process.
- Work with the leadership team to review project budgets and resources to ensure they are in line with objectives.
- Build trust and strong relationships with key partners and stakeholders across the company.
- Remain current on industry trends and advises the organization regarding scientific matters.
- Plan, support, and execute PGDx’s product development strategy.
- Build and manage the clinical data and analysis capability to accommodate development programs.
Education and/or Work Experience Requirements:
- Ph.D. Degree in Biology or Related Field with a minimum of 7+ years’ experience in molecular diagnostics or medical device industry; Master’s degree with 10+ years of relevant experience;
- Design control expertise required
- Experience with Companion Diagnostic programs and FDA submissions highly preferred
- Understanding of cancer biology principles and familiarity with solid tumors and hematological malignancies.
- Expertise in disease-relevant biomarker discovery and validation strategies.
- Experience with early scientific development in areas such as cell therapy, immuno-oncology and genetic regulation.
- Must have prior research scientist experience.
- Familiarity with diagnostic approaches, including NGS, LDT, CLIA, IVD products and Companion Diagnostics.
- Must have Diagnostic and/or Pharmaceutical industry experience.
- Proven publication and patent submission track record.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement .
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