Sr. Principal Scientist, PKS, NITD

319376BR
May 18, 2021
USA

Job Description

6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.

The PKS Group at Novartis Institutes of Biomedical Research is seeking a highly motivated drug metabolism and pharmacokinetics scientist. As a Senior Principal Scientist you will be deployed as a PKS project team representative to discovery through development projects to provide timely, comprehensive, and value-adding support for projects, and will seek to understand complex DMPK, pharmacology and toxicology related issues and strategies to optimize the overall properties of compounds and successfully shepherd compounds through preclinical and clinical development. You will have excellent scientific, interpersonal and communication skills, and will effectively operate and influence in a highly matrixed team environment.

Your accountabilities will be but not limited to:
• Responsible for efficient, innovative, and timely preclinical and clinical PK and PK/PD support including but not limited to developing project strategy and supportive study design, analysis, interpretation, and reporting to support international regulatory submissions.
• Provide small and large molecule clinical pharmacology expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA).
• Responsible for design, analysis and communication of data on clinical pharmacology studies. Develop and implements new clinical pharmacology studies that impact development programs.
• Effectively represent clinical pharmacology in cross-functional study-team settings
• Work in close partnership with Chemistry, Preclinical Toxicology, Project Management, translational medicine, Biostatistics and other partner functional areas to support clinical development programs.

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you will bring to the role:

Requirements:

• PharmD or PhD, with pharmacokinetic training, fellowship and/or postdoctoral experience and 5+ years of clinical pharmacology/pharmacokinetics
• Strong understanding of clinical pharmacokinetic concepts is required
• Training/experience in advanced pharmacokinetics, clinical pharmacology and/or pharmacy with clinical research, drug development is desirable
• Understanding of discovery and drug development process to provide clinical pharmacology support for clinical development (Phase 1 to Phase 4) for investigational agents and/or marketed drugs
• Proficiency in the design and analysis of experiments to define quantitative preclinical PK/PD/efficacy relationships is desired
• Experience with small molecule and biologic drug discovery and development preferred.
• Experience with different routes and methods for drug delivery, including inhalation delivery preferred.
• Ability to leverage modeling and simulation approaches to build an early understanding of predicted human PK, dose and drug/drug interactions.
• Hands-on experience in clinical trials management/study conduct and/or basic laboratory sciences is desirable
• Must have established computer skills with detailed knowledge of PK programs and analysis software (e.g. WinNonlin), along with experience with scientific graphing and analysis software (Sigma plot, GraphPad, Instat, etc). Must have excellent written and verbal communication skills.

Why Novartis?

769 million patients were impacted by Novartis products in 2020.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.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. 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.
NIBR
Translational Medicine
USA
Cambridge, MA
Research & Development
Full Time
Regular
No
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319376BR

Sr. Principal Scientist, PKS, NITD

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