Director Clinical Science Roche Tucson

Job Description: • 2-minute read •
As a Clinical Science Director, you will develop, lead and manage robust clinical validation strategies for 510(k) and PMA level in vitro diagnostic assay registration programs. Work collaboratively with the heads of Clinical Operations, Biostatistics and Data Management, and the Pathology Office as part of the strategic clinical trial core team to ideate, develop and finalize the clinical registration strategy with a focus on intended use statements, clinical trial design and sampling strategy for cancer diagnostics projects.
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You will work collaboratively with Clinical Operations to ensure full and accurate implementation of medical strategies into project specific clinical trial programs. Also responsible for ensuring that these activities are accomplished in close collaboration with relevant key opinion leaders (KOLs) and the Lifecycle project teams. Scope of responsibilities will include external registration studies such as clinical utility, diagnostic utility, reproducibility and method comparison studies. The Clinical Science function also works cooperatively with the Medical Affairs function to align on study activities and strategy including input as appropriate to the post-launch medical plans for cancer diagnostics portfolio projects.

Essential functions of your Clinical Science Director role include the following:
Creates, implements and manages clinical validation and registration plans for cancer diagnostics as part of the clinical trial core team consisting of Clinical Science, Clinical Operations and Biostatistics.
Manages the design, implementation, interpretation, reporting and publishing of clinical research studies to support cancer diagnostic product registrations. Identifies suitable academic partners, external laboratories and clinical sites to participate in clinical studies in collaboration with Clinical Operations.
Provides medical/scientific input into and assists with the preparation of FDA regulatory submissions (PMAs and 510(k)s). Prepares and provides responses to questions and requests from FDA and represents the medical interests of the projects during FDA interactions.
Provides medical strategy expertise and leadership across the organization. Provides medical expertise to all functions and works in collaboration and alignment with all relevant stakeholders such as the Lifecycle teams, Project leaders, Regulatory, Quality, Research, Medical Innovation, Pathology Office, Development, Finance, and Project Management Office functions.
Serves as liaison for Clinical Science activities across Roche Molecular Solutions and with other Roche Diagnostics Business Areas. Works as a scientific and medical/clinical liaison between internal teams and external groups such as CROs, and professional and public health organizations.
Works in collaboration with Medical Affairs group to generate and/or review medical and scientific information materials including scientific publications, abstracts, posters, and whitepapers relating to cancer diagnostics registration study programs.

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