Associate Pathologist Director

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

PURPOSE

The review and reporting of Anatomic Pathology samples in accordance with applicable regulations governing clinical laboratories. 

Serving as the Expression Analysis -Q2 CLIA Lab Director

• RESPONSIBILITIES
• Review and report surgical pathology and cytology samples including routine H&E staining, Immuno-histochemistry and FISH assays on a daily basis.
• Serve as the EA (Q2-RTP) CLIA Lab Director and maintain credentials to support CLIA regulations for High Complexity testing labs including acceptable board certifications.   This includes all qualifications to meet the NY State CLIA Oncology – Molecular and Cellular Tumor Markers Certification.
• Provide recommendations on appropriate protocols and policies for implementing genomic based CLIA-level assay as the genomic AP and Molecular Pathology Subject Matter Expert globally for Q2.
• Establish the AP laboratory from the ground up at EA-QRTP including (but not limited to) implementation of globally harmonized protocols, evaluation and selection of equipment, layout and workflow of the physical laboratory space, drafting and finalizing SOP’s, implementing relevant proficiency evaluation processes, and hiring and training of staff. 
• Ensure reporting is completed within the TAT required for the assay/ study.
• Comply with the international standards for scoring of the assays and participate in peer review programs, CAP proficiency surveys on a regular basis.
• Participate in the development and validation of new assays in AP or Genomics lab with review and interpretation of results for new assays on a regular basis. Involved in trouble shooting and resolution of technical issues related to assay protocol.
• Participate in the training sessions with pharma and other diagnostic partners for scoring of new assays leading to certification and subsequent analysis of patient samples.
• Participate in sponsor discussions for new study requests and / or new assay development as and when required.
• Participate in scientific review for new study requests, provide pathologist expertise and input for the study requirements as and when required.
• Ensure that the highest standards of quality and customer service are maintained. Collaborate with Quality Assurance staff on development and implementation of effective programs. Monitor outside proficiency testing program as required; take corrective action promptly when results are unsatisfactory.
• Establish effective staff selection and training program to ensure that qualified staff are hired and continuously trained in order to remain current on testing procedures.
• Keep abreast of new technical developments. Implement new tests, equipment, programs and/or procedures in the department as needed. Lead continuous improvement initiatives to increase quality of services and operational efficiency.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• In depth knowledge of clinical testing procedures and applicable laboratory testing regulations

*In depth knowledge of molecular pathology and complex genomic testing assays including Next Generation Sequencing, and their applicability in clinical trials.

• Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific program requirements

• Knowledge of occupational safety and health rules and regulations

• Excellent written and oral communication skills

• Excellent client management and problem resolution skills

• High ethical standards

• Ability to assess and prioritize multiple tasks, projects and demands

• Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• MD with Board certification in Anatomic Pathology with experience in Molecular Pathology. 

• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

*Experience in Molecular Pathology is an advantage.

*Experience as an Anatomic Pathologist in either hospital or pharmaceutical industry is an advantage.

PHYSICAL REQUIREMENTS

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech

• Extensive use of keyboard requiring repetitive motion of fingers

• Regular sitting for extended periods of time

• Extensive use of microscope

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.