Senior Principal Scientist/Associate Director Clinical PBPK (Dual Level Posting)

Summary

The Modeling & Simulation group within PK Sciences is actively seeking a skilled individual to develop and apply translational physiologically based pharmacokinetic (PBPK) modeling, along with data analysis techniques. This role is integral in facilitating drug discovery, development, and translational research across various disease areas. A key focus is to ensure successful regulatory interactions and submissions.

Key Responsibilities

• Serve as an expert PBPK modeler, providing crucial modeling support for global drug discovery and development projects.
• Conduct translational PBPK analyses predicting clinical drug exposure in specific populations, assessing potential for drug-drug interactions (DDI), and understanding the clinical impact of diseases on drug exposure.
• Employ biopharmaceutic PBPK modeling to support formulation changes and achieve clinical biowaivers.
• Integrate pharmacokinetics (PK) and pharmacodynamics (PD) data along with ADME and DDI findings.
• Interpret and effectively communicate modeling results and their potential impact to project teams.
• Prepare summary documents for regulatory submissions, addressing inquiries from health authorities independently.

Essential Requirements

• PhD in pharmaceutical sciences or a related discipline, with a strong background in ADME/DMPK sciences, biopharmaceutics, and modeling and simulation, complemented by at least 5 years of experience in the pharmaceutical industry.
• Hands-on expertise with PBPK modeling tools such as PK-Sim, Simcyp, or GastroPlus is essential, with additional experience in Monolix, R, Phoenix, or Nonmem desired.
• Proficient in authoring regulatory documents, with a comprehensive understanding of global regulatory requirements and guidelines.
• A broad knowledge base encompassing the drug discovery and development process, including pharmacokinetics, drug delivery, formulation, ADME, and DDI.

Work Environment

This hybrid role necessitates a mix of in-person and virtual work, with approximately 12 days per month required on-site in Basel, Switzerland. Candidates demonstrating impactful modeling experience, preferably within the pharmaceutical or biotech sectors, will be considered for either the Principal Scientist II or Associate Director position.

Benefits & Rewards

At Novartis, we are dedicated to redefining medicine and rewarding those who contribute to this mission. The expected annual base salary range for this position is between CHF 122,500 and CHF 227,500. In addition to the base salary, performance-based bonuses may be available based on specific performance metrics.

Beyond competitive pay, our offerings include a diverse range of benefits designed to support both personal and professional growth. These benefits encompass insurance plans, retirement options, wellness resources, and opportunities for global recognition, alongside flexible and hybrid working arrangements where feasible. We also provide a minimum of 14 weeks of paid parental leave.

Commitment to Diversity and Inclusion

We are committed to fostering an inclusive work environment that reflects the diversity of the communities we serve. Our policies are designed to ensure that all employees are treated with dignity and respect.

Why Join Us?

At Novartis, we recognize that combating disease requires more than groundbreaking science. It demands a community of intelligent, passionate individuals who support and inspire one another. Together, we strive to achieve breakthroughs that will change the lives of patients. Join us in creating a brighter future.