Assistant Medical Director
Remote - PA Bryn Athyn, PA 19009 US
The candidate will bring technical expertise into our CLIA/CAP laboratory. The laboratory performs high complexity tests, including NGS, to support commercial laboratory operations and Biopharma clinical studies.
The candidate must have an interest in working within a highly collaborative, multidisciplinary environment (including bioinformatics, assay development and engineering), and have the ability to forge strong links with individual contributors and cross-functional teams including staff pathologists. They must also be able to provide consultative expertise and molecular interpretation for clinical applications of DNA/RNA-based assays of different tissues. This role requires leadership skills in data analysis, experimental design, and troubleshooting of sequencing results. The candidate will be involved in analyzing complex sequencing data, software development, laboratory process improvements, training, and reporting patient results from the CAP/CLIA lab. The candidate must be able to quickly adapt to changing priorities and work well in fast pace environment, and prioritize risks and implements contingency plans.
The Assistant Medical Director reports to the VP of Operations & Site Manager, North America.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 1. Ensure customer satisfaction through high quality, efficient and reliable laboratory services.
2. Oversee personnel training, development, performance, and professional growth.
3. Oversee interactions with customers (contracting, data transfer, logistics and daily operations) and regulatory agencies (audits, licensure).
4. Ensure consistency in global testing results.
5. Host internal and external audits and respond to audit findings as needed.
6. Liaise with Marketing, QC, QA/RA and R&D to provide new assays and testing capabilities in response to market demand within a quality, regulatory compliant
7. Manage licenses and accreditations, including CLIA/CAP, NYS and ISO15189.
8. Oversee creation and approve Standard Operating Procedures to ensure compliance and efficiency of operations.
9. Oversee clinical lab external vendor contracts and interactions (e.g. LIMS).
10. Assist with review of customer contracts and Statements of Work and provide feedback to sales and marketing as needed.
11. Provide scientific knowledge regarding clinical lab operations and company technologies.
12. Oversee preparation of materials and manage Quality Management Reviews, including Key Performance Indicators.
13. Support VP of Ops & Site Manager in creating and managing budget for the Clinical Lab.
14. Assist VP of Ops & Site Manager in preparing monthly reports for invoicing and KPIs.
Education Requirements • Earned doctoral degree (PhD, ScD) in a chemical, physical, biological or clinical laboratory science.
- A minimum of 2 years of relevant experience in a CLIA/CAP laboratory
- Specific experience in developing and validating NGS-based molecular tests and in bioinformatics of NGS-based molecular assays.
Supervisory Responsibility - this position includes overseeing of global laboratory operations and personnel.
Work Environment This job operates in an office and clinical laboratory setting.
This is largely a sedentary role. However, it will require the ability to lift files, open filing cabinets and bend or stand as necessary.
Pay Rate Range: $100-140/hr. Salary will be commensurate with experience
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