Under direction from the Chair of the Department of Pathology and Laboratory Medicine the Clinical Trials Medical Director is responsible for leading the clinical aspects of the Clinical Trials department. The Medical Director serves as a key clinical resource for Clinical Trials clients (Pharmas, CRO’s, Medical Centers) in particular interacting with Sponsors, Principal Investigators and Medical Monitors. The Medical Director ensures the technical accuracy and medical reliability of the Clinical Trials processing and testing by actively participating in all aspects of the section’s Quality Management program, and ensures that all regulatory expectations are met. Works closely with the Clinical Trials Administrative Director & Department Program Administrator in matters related to finance, personnel management, regulatory compliance and strategic planning.
Responsible to the Chair of the Department of Pathology and Laboratory Medicine.
The Medical Director will be responsible for the overall medical/clinical aspects of the Clinical Trials department.
Provides medical support, expertise and guidance to both internal and external study project teams on clinical issues to ensure that clinical studies are conducted according to the highest ethical principles and in compliance with all applicable legal and regulatory standards.
Contributes to investigator meeting presentations and reviews study documentation. Participates in all study Risk Assessment reviews.
Provides consultation to the study team during review of study protocol, out-of-range laboratory values or situations where sample integrity/ stability concerns arise.
Reviews and approves protocol for Sponsor defined ranges/alerts and discuss with Sponsor as appropriate
Reviews and monitors clinical data and reviews and interprets results.
Responsible for remaining current on all developing technologies.
Approves new Clinical Trials specific technical procedures and reviews all current Clinical Trials specific procedures on an annual basis.
Partners with Clinical Trials Scientific Affairs team to review lab testing requirements, sample types, volume, storage, shipment for any non-routine testing.
Partners with UR Medicine faculty to source requested study specific testing or participate in the development of study specific testing not currently offered within the University of Rochester laboratory network.
Participates in of the Laboratory’s Quality Management System (QMS), in partnership with the Administrative Director for Clinical Trials and the Administrative Director of Quality.
Participates in the development of and reviews all clinically related quality metrics and reports, as applicable.
Participates in Clinical Trials client and regulatory audits and ensures resolution of clinically related citations and implementation of recommendations.
Approves selection of reference laboratories for any study specific tests which are not performed within the University of Rochester laboratory network.
Ensures effective and compliant administration, including development of strategic plans to increase revenues/decrease expenses, maximize efficiency, manage personnel, and meet regulatory requirements.
Works to build effective working collaborations with faculty and staff in the department and within the Medical Center. Leverages the capabilities of the faculty and areas of expertise to expand market share and to further differentiate our Clinical Trials product.
Possesses MD (or equivalent) or PhD
MD (or equivalent) – Pathologist must be Board Certified or Board eligible in Clinical Pathology or Clinical Pathology & Anatomic Pathology.
PhD with additional Fellowship training in Clinical Laboratory Medicine – Clinical Chemistry, Clinical Microbiology/ Immunology, Clinical Molecular Diagnostics.
Interested individuals should apply on-line to Job posting #243787 at http://www.rochester.edu/working/hr/jobs/
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
The University of Rochester is responsive to the needs of dual career couples.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 000 Pathology & Lab Medicine M&D