Senior Principal Scientist/Associate Director Clinical PBPK (Dual Level Posting) at Novartis AG
berlin, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

22 Dec, 26

Salary

100000.0

Posted On

23 Sep, 26

Experience

18 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description

Job Description

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


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Responsibilities

Job Description

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

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