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Principal Scientist I, M&S Pbpk

2+ years
Not Disclosed
10 July 31, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

Internal Role Title: Principal Scientist I, Modeling & Simulation
Location: East Hanover, NJ or Cambridge, MA #LI-Hybrid
Note: This position requires on-site presence at one of the specified locations and cannot be performed remotely.

About the Role:
In Translational Medicine (TM) at NIBR, we are dedicated to bridging the gap between drug discovery and clinical application. PK Sciences (PKS) within TM collaborates with both NIBR and Global Drug Development to advance pharmacokinetics, metabolism, and clinical pharmacology. We are seeking a Principal Scientist I to join the Modeling & Simulation group within PKS. This role involves developing and applying translational physiologically based pharmacokinetic (PBPK) modeling to support drug discovery, development, and translational research across various disease areas. The focus is on integrating in vitro and in vivo data for drug-drug interaction (DDI) assessments, understanding the impact of biopharmaceutic properties on absorption, and predicting pharmacokinetics in humans and specific populations.

Key Responsibilities

  • PBPK Modeling: Conduct translational PBPK analyses to predict clinical drug exposure in specific populations, assess DDI potential, understand the impact of disease on drug exposure, and support formulation changes.
  • Data Integration: Integrate pharmacokinetics (PK), pharmacodynamics (PD), absorption, distribution, metabolism, excretion (ADME), and DDI findings.
  • Communication: Interpret and communicate modeling results to project teams, and prepare summary documents for regulatory submissions, addressing health authority queries independently.

Essential Requirements

  • Education: PhD in pharmaceutical sciences or a related discipline. Experience in ADME/DMPK sciences, biopharmaceutics, and modeling and simulation is strongly preferred.
  • Experience: Hands-on experience with PBPK modeling tools such as PK-Sim, Simcyp, or GastroPlus is preferred. Familiarity with modeling software like Monolix, R, Phoenix, or Nonmem is a plus.
  • Knowledge: Fundamental understanding of drug discovery and development, including pharmacokinetics, drug delivery, formulation, ADME, and DDI.

Compensation and Benefits

  • Pay Range: $130,400 to $195,600 per year. Final pay will be based on factors such as location, experience, skills, and market conditions. The total compensation package may include a sign-on bonus, restricted stock units, discretionary awards, and a comprehensive benefits package, including 401(k) eligibility and various paid time off benefits.
  • Benefits: Details available in the Novartis Life Handbook.

Why Novartis?

Novartis is committed to reimagining medicine to improve and extend lives. We believe that achieving breakthroughs requires a collaborative and supportive community. Join us to contribute to this mission and explore our values and culture here.

Join Our Network: If this role isn't the perfect fit, join our Novartis Network to stay updated on future opportunities.

EEO Statement: Novartis is an Equal Opportunity Employer. We are committed to maintaining a diverse and inclusive environment and do not discriminate in recruitment, hiring, training, or other employment practices.

Accessibility & Reasonable Accommodations: For reasonable accommodations due to a medical condition or disability, contact us at us.reasonableaccommodations@novartis.com or call +1(877)395-2339, including the job requisition number in your message.

Division: Biomedical Research
Business Unit: Pharma Research
Location: USA
Site: Cambridge (USA)
Company / Legal Entity: Novartis Institutes for BioMedical Research, Inc.
Functional Area: Research & Development
Job Type: Full time
Employment Type: Regular
Shift Work: No