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Associate Director, Companion Diagnostics Oncology

Collegeville, Pennsylvania
Closing date
Jul 8, 2022

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Details Develop, lead, and coordinate activities related to the development and commercialization of companion diagnostics across multiple therapeutic areas, with a focus on the safe and effective implementation of companion diagnostics in patients with cancer. Accountable for all aspects of companion diagnostics development, from research study design through to clinical implementation. Play a critical role throughout the companion diagnostic development process. Lead companion diagnostics strategy within early and late-stage therapeutic oncology programs to align companion diagnostic development milestones with associated clinical development milestones and overall biomarker strategy for GSK's oncology assets currently in development. Oversee the technical aspects of development, which includes assay validation and clinical implementation of the selected assays. Ensure that diagnostic testing and data generation is compliant with all regulatory requirements for advancing devices through development and onto the market. Support scientific work and develop research studies related to companion diagnostic development. This includes participating in the scientific evaluation of advanced technologies for in vitro devices (“IVD”) and clinical biomarker development. Provide support for product claims and provide consultation, review, and guidance to support product registration with regulatory bodies. Author companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, Investigational Device Exemption (IDE) and Premarket Approval (PMA) regulatory submissions. Work with an external IVD partner to develop, validate, register, and commercialize companion diagnostic tests for prospective patient selection.

Basic Qualifications Must have a Master's degree (or foreign equivalent) in Pharmaceutical Sciences or a related field and 4 years of experience in: (1) Work with a cross-functional team with limited guidance that supports clinical trials testing new targeted anti-cancer drugs, by developing tailored companion diagnostic assays; (2) Design and conduct studies with independence, including troubleshooting as required; (3) Evaluate performance testing of companion diagnostic assays including, IHC, FISH, NGS, or PCR assays; (4) Support clinical trial activities including preparation of study materials and training of study personnel; (5) Define and design the optimal development path for each product within our workflow and adhering to a quality management system framework; and (6) Evaluate and report experimental results. Generation of general protocols, reports and publications.

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