Principal / Senior Principal Pharmacometrics

285754BR
Principal / Senior Principal Pharmacometrics

Job Description

Principal / Senior Principal Pharmacometrics

85 quantitative scientists in Novartis are supporting more than 80 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. Quantitative scientists in pharmacometrics collaborate with cross-functional international teams and develop models characterizing exposure-response, disease progression, biomarker and diagnostic assays. These models allow optimal decision making on key development questions such as dose selection and treatment.

Come to an industry leader where you will have the opportunity to provide quantitative support for early and late clinical drug development. The successful candidate will lead the planning, execution and delivery of pharmacometric strategy on assigned projects within (early/full) clinical development. S/he is responsible for the discussion and implementation of pharmacometric methodologies that optimally address the research and development objectives on the assigned projects. S/he provides pharmacometric support for regulatory submissions, and contributes to drug development decisions with internal and external partners.
Accountabilities
•Develop, write and execute pharmacometric analysis plans, and deliver reports on results.
•Assess pharmacometric requirements for, and ensure integration of pharmacometric information into transition of 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 the provision of pharmacometric contributions to regulatory/submission strategy and related documents: (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, and responses to Health Authority questions) with oversight.

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.

Minimum requirements

Position will be filled at level commensurate with experience

(May be hired at the Principal and Senior Principal levels)

Education
PhD or PharmD in Pharmaceutical sciences, Clinical pharmacology, mathematics, statistics, engineering or other quantitative discipline preferred

Experience
•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
•Clinical, pharmacological and therapeutic knowledge of at least one disease area
•Good interpersonal and communication skills (verbal and writing) to bridge scientific and business needs, integrating quantitative sciences
•Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development

Why consider Novartis?

750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.
Global Drug Development
CD&A GDD
USA
Cambridge, MA
NIBRI
Research & Development
Full Time
Regular