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PKS Investigator, Discovery through Development

Position Title: PKS Investigator, Discovery through Development
Job ID: 258870BR
Division: NIBR
Business Unit: Translational Medicine
Location: USA
Site: Cambridge, MA
Company/Legal Entity: NIBRI
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
For More Information ... TO APPLY:

Job Description:
6500! 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.
PK Sciences (PKS) is a global organization of about 300 associates, situated within Translational Medicine (TM), the clinical research arm of NIBR. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application. PK Science is an enterprise organization, working across both NIBR and the Global Drug Development (GDD) organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology.
We are seeking a project team member to join the PKS team at the Cambridge, MA location. He/she will collaborate with business partners to select and characterize new chemical and biologic entities from research and advance promising entities into the clinic. The qualified candidate will represent the PK/PD/ADME discipline on discovery and development project teams, and suggest and implement strategies and tactics to advance high-quality entities as part of the overall program(s).
The position is an individual contributor in therapeutic areas that focus on, but are not limited to, indications in liver, kidney and hematologic diseases. The NIBR portfolio consists of projects using several therapeutic modalities including small molecules, biologics, gene therapy and cell-based therapies.
Responsibilities include:
  • The individual will represent the PK/PD/ADME discipline, and serve as the primary source of scientific expertise on global cross-functional project teams, leading the design, execution, and analysis of PKS preclinical and clinical studies.
  • Working with subject matter experts in PKS and partner groups, support the efficient application and integration of modeling and simulation tools to advance lead optimization and clinical candidate selection
  • Make use of PKS resources across NIBR organizations to drive project efforts; ensure an aligned position on research strategy and in particular human PK/PD and dose projections as candidates transition into the clinic
  • Support PKS components of preclinical and clinical study protocol designs, preclinical and clinical study reports, and investigator brochures, etc. Prepare for Health Authority calls/meetings/discussion and be responsible as PKS representative in these settings
  • Collaborate with other NIBR and GDD functions, bring innovative ideas and approaches, and a leadership, enterprise mindset that inform and influence the overall drug discovery and development process. 
Minimum requirements:
  • PhD in pharmacology/physiology, biochemistry, chemistry, pharmacokinetics/pharmaceutical sciences, or related sciences.
  • A good understanding of the drug discovery and development process, with a minimum of 3+ years in a drug discovery setting in industry.
  • Familiarity with standard ADME/PK modelling tools such as Phoenix, GastroPlus, etc.
  • Hands-on project experience with low molecular weight and biologics modalities desirable; and cell-based and/or gene-based therapies highly desirable.
  • Experience in authoring regulatory documents, knowledge of global regulatory requirements and guidances desired.
  • Excellent written and oral communication skills is a must.
927 million. That’s how many lives our products touched in 2017. And while we’re proud of that, 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 empowered to ask new questions, make bolder decisions and take smarter risks. We are Novartis. 
Join us and help reimagine medicine.

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.