March 12, 2021 at 4:15 am #6637prasad157Participant
Principal/Sr. Principal Pharmacometrician – Oncology | Novartis (brassring.com)
100+ quantitative scientists in Novartis are supporting early clinical development projects in 10 therapeutic areas every day, who transform clinical data into analyses that build the basis for making innovative drugs accessible for patients. We collaborate with cross-functional international teams and develop models characterizing exposure-response, disease progression and biomarker response. These models allow optimal decision making on key development questions such as dose, regimen and benefit risk ratio.
Early Development Analytics (EDA) is a fully integrated (Biostatistics, Digital & Discovery, and Pharmacometrics) function providing quantitative leadership for early clinical development at Novartis across disease areas. Come to an industry leader where you will have the opportunity to provide quantitative insight for early clinical drug development in Oncology within EDA. The successful candidate will lead the planning, execution and delivery of innovative pharmacometric strategies for projects in early clinical development oncology. They’ll be responsible for the discussion and implementation of pharmacometric methodologies that address the research and development objectives on the assigned projects. Position will be filled at level commensurate with experience – (May be hired at the Principal and Senior Principal levels)
What you’ll be doing
• Develop, write and execute pharmacometric analysis plans, and deliver reports on results.
• Assess requirements for, and ensure integration of pharmacometric information into drug development milestones / decision boards.
• Align with the Analytics team (biometrics, data management, database programming, programming, medical and scientific writing) on the pharmacometric strategy, execution and delivery of assigned projects.
• Lead and optimize contributions to regulatory/submission strategy and related documents: (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, and responses to Health Authority questions)
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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
What you’ll bring
• PhD with (3+ years’ for Senior Principal) experience in modeling and core expertise in NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation in academia and/or industry
• PhD or PharmD in Pharmaceutical sciences, Clinical pharmacology, mathematics, statistics, engineering or other quantitative field preferred
• Clinical, pharmacological and therapeutic knowledge of oncology
• Good interpersonal and communication skills (verbal and writing) to bridge scientific and business needs, integrating quantitative sciences
• Skilled in the application of pharmacometrics approaches to drug development
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