Precision Medicine Director-Safety Biomarker

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POST DATE 9/14/2016
END DATE 10/26/2016

Novartis Oncology East Hanover, NJ

East Hanover, NJ
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


The Precision Medicine Director (PMD), supports the Disease Area Precision Medicine Leader (PML) by, contributing to the development of the Oncology Precision Medicine (OPM) Strategy for a given disease area GPT. The PMD leads and oversees all aspects of implementation and execution of the disease area OPM strategy, with predominant focus on timely execution of biomarker activities to support decision making in the GPT and ensuring regulatory approval, of any CDx assays in collaboration with the CDx Regulatory team. br br . 1. Functionally and operationally reports to the VP, Global Head of Correlative Sciences Center of Excellence (CS-CoE) and br br 2. Contributes to the design of the disease area OPM strategy in support of a GPT. Responsible for the implementation & execution of the OPM strategy br br 3. Ensures timely execution of assay development for patient selection, stratification, pharmacodynamics, correlative studies and CDx development for clinical trials by working with internal stakeholders (global line functions) and external partners (clinical research organizations, Academic Labs, clinical labs and diagnostic partners) for assigned program(s) with limited oversight br br 4. Contributes input to the PML and clinical team for assay development, molecular epidemiology, and other research-related activities with other internal stakeholders. Defines the vision, the target test profile, the key claims portfolio and the platform strategy, the overall CDx development strategy and plan based on regulatory and commercial/consumer requirements/needs that overall lead to a new diagnostic test. Drive and steer the implementation of the Program's strategic plan in close collaboration with the PML and other team members (including disease area project management, BDM, BCM, and others as needed) within the accepted timelines, budgets and resources at the required quality level. br br 5. Leads companion diagnostic development as needed, and serves as a member of PML core team and International Clinical Team (ICT) and other teams where implemented. br br 6. In collaboration with TCO/NIBR, identify and validate external laboratories involved in CTAs for clinical trials and companion diagnostic development. br br 7. Authors the biomarker/CDx portions of key clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports (CSRs) br br 8. Supports regulatory submissions by acting as subject matter expert within the team. Contributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, and submission documents (including NDAs, IDEs & PMAs). Coordinates data requirements with reference labs to support submission. br br 9. Partners with Biomarker Trial Heads (BTHs) and other internal stakeholders to ensure all aspects of data collection are executed with high quality, including correlative science analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for correlative study samples. br br 10. Actively educates other team members through knowledge sharing. Contributes to the development and implementation of processes supporting patient pre-selection and stratification, pharmacodynamic monitoring,correlative studies & requirements for CDx development br br 11. Acts as core member of the International Clinical Team br br 12. Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s). In case issues cannot be avoided, ensures that they are being resolved employing the full technical and strategic expertise and experience of the organization thus limiting negative impact on the program(s) br br 13. Compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System. br br b EEO Statement /b br The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. br