Principal Scientist II to Senior Principal Scientist, Clinical PBPK Modeling & Simulation

Summary

#LI-Hybrid

Internal Title: Principal Scientist II or Senior Principal Scientist (DUAL LEVEL)

This position will be based in Cambridge, MA and will not be located remotely.

The Modeling & Simulation group within PK Sciences is looking for a Principal Scientist II or senior Principal Scientist level modeler, 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. Importantly, the candidate has experience with regulatory submissions and in successful regulatory interactions. 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.

You will have the opportunity to work in a dynamic and multidisciplinary environment to build, verify and apply quality translational/biopharmaceutical PBPK models.

About the Role

Key Responsibilities:

• Expert PBPK modeler to provide translational modeling support for global drug discovery and development projects
• 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
• Ability to 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:

• PhD in pharmaceutical sciences or related discipline with experience in ADME/DMPK sciences, biopharmaceutics, and modeling and simulation.
• 3+ years in pharmaceutical industry including demonstrated knowledge and experience with PBPK modeling. To be considered at the Sr. Principal Scientist level, at least 6 years of industrial experience.
• Hands on experience with PBPK modeling tools such as PK-Sim, Simcyp, or GastroPlus is required. In addition, experience with modeling software such as Monolix, R, Phoenix, or Nonmem is desired.
• Experience in authoring regulatory documents, knowledge of global regulatory requirements and guidance.
• Broad knowledge of drug discovery and development, e.g., pharmacokinetics, drug delivery, formulation, ADME, DDI, etc.

This is a dual level posting. The final level and title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.

The salary for this position is expected to range:

Principal Scientist II: between $119,700 and $222,300 per year.

Senior Principal Scientist: between $152,600 - $283,400 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here .

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The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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