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

Senior Principal Scientist Or Associate Director

The Modeling & Simulation group within PK Sciences is looking for a Principal Scientist to Associate Director 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.

The role requires a deep understanding of ADME/DMPK principles and biopharmaceutics knowledge, experience with industry standard PBPK modeling packages (such as GastroPlus or Simcyp) or bespoke PBPK models, regulatory submissions involving PBPK modeling, interdisciplinary thinking and great attention to detail. The applicant will work in a dynamic and multidisciplinary environment to build, verify and apply quality translational/biopharmaceutical PBPK models.

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. At least 5+ years in pharmaceutical industry including demonstrated knowledge and experience with PBPK modeling. The level of the position would depend upon the experience of the candidate.
• 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 hybrid role that requires a balance of in-person and virtual working, with an average of 12 days a month on site in Basel, Switzerland.

Candidates with demonstrated impact as a modeler, preferably in the pharmaceutical/biotech industry, and with commensurate experience and proficiency may be considered for the Principal Scientist II (5+ years) or Associate Director (8+ years) role.

This is a dual posting. The final level & 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

Expected Annual Base Salary Range for role:

• 122,500.00 – 227,500.00 CHF Annual

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

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

Skills Desired: Algorithms, Clinical Trials, Data Engineering, Innovation, Mentorship, Simulation Software, Waterfall Model