Principal Scientist I, M&S PBPK

Job Description Summary

About the role :

#LI-Hybrid

This position can be based at our East Hanover, NJ or Cambridge, MA campus and will not have the ability to be located remotely.

About the role:

Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. PK Sciences (PKS), within TM, collaborates across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology.

The Modeling & Simulation group within PK Sciences is looking for a Principal Scientist I to develop and apply translational physiologically based pharmacokinetic (PBPK) modeling along with data analysis techniques to facilitate drug discovery, development, and translational research across disease areas. The candidate’s core responsibilities will include PBPK modeling to integrate in vitro and in vivo data for drug-drug interaction (DDI) assessments, impact of biopharmaceutics properties on absorption, and pharmacokinetic (PK) predictions in humans as well as in specific populations (e.g. disease, organ impairment, pediatrics). The ultimate goal of this work is to be on the forefront of applying PBPK models to inform the safe administration of our drug candidates in the clinic, to optimize clinical trial designs, and waive clinical trials, ultimately, to get our medicines to patients faster.

 

Job Description

Your Key Responsibilities: 

• Perform translational PBPK analyses to predict clinical drug exposure in specific populations, assess potential for DDI, understand clinical impact of disease on drug exposure, as well as apply biopharmaceutic PBPK modeling to support formulation changes and achieve clinical biowaivers
• Integrate PK/ PD data, ADME and DDI findings
• Interpret and communicate modeling results and potential impact to project teams
• Prepare summary documents for use in regulatory submissions and ability to respond independently to health authority questions

Essential Requirements:

As a Principal Scientist I in PBPK you will have an understanding of ADME/DMPK principals and biopharmaceutics knowledge, some experience with industry standard PBPK modeling packages (such as GastroPlus or Simcyp) a plus. You will work in a dynamic and multidisciplinary environment to build, verify and apply quality translational/biopharmaceutical PBPK models.

Essential Requirements: 
• PhD in pharmaceutical sciences or related discipline; experience in ADME/DMPK sciences, biopharmaceutics, and modeling and simulation strongly preferred.

• Hands on experience with PBPK modeling tools such as PK-Sim, Simcyp, or GastroPlus is preferred. In addition, experience with modeling software such as Monolix, R, Phoenix, or Nonmem a plus.
• Fundamental knowledge of drug discovery and development, e.g., pharmacokinetics, drug delivery, formulation, ADME, DDI, etc. desirable.
 

Benefits and Rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $130,400 to $195,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any