PKPD Senior Principal Scientist

Cari; København; Hybrid; DKK 847,000 - 1,245,000; Full time

Job summary

Cari seeks a PKPD Senior Principal Scientist to shape translational modelling strategies across drug discovery and development. You will set direction for PKPD approaches, connect preclinical evidence with human safety and efficacy, and guide interdisciplinary teams through a diverse research portfolio.

Lead preclinical PKPD study design, build mechanistic models, run human PKPD simulations, advise on dose selection and trial design, contribute to regulatory documentation, and mentor scientists

Qualifications

• PhD combined with substantial pharmaceutical industry experience.
• Ideally, at least ten years of relevant pharmaceutical/biotech experience.
• Strong knowledge and hands-on PKPD, quantitative systems pharmacology and/or PBPK modelling.
• Experience developing mechanistic and empirical models for biological processes.
• Proficiency with pharmacokinetic modelling software (Phoenix WinNonlin/NLME, NONMEM) and analytics (R, Python, MATLAB).
• Strong communication and stakeholder management skills to influence cross-disciplinary decisions.

Responsibilities

• Set direction for translational PKPD screening and mechanistic modelling with researchers and clinicians.
• Design preclinical PKPD studies, interpret results, and communicate conclusions to support decisions.
• Build mathematical models and run simulations of human PKPD using in-house and literature data.
• Guide study design, dose setting for toxicity, first-in-human dose and clinical trial planning.
• Contribute to regulatory interactions and dossiers with scientific input.
• Mentor scientists and advance capabilities in mechanistic modelling and PKPD.

Skills

PKPD modelling

Quantitative systems pharmacology

Mechanistic modelling

Communication & stakeholder mgmt

Pharmacokinetic modelling software

Python/R/MATLAB scripting

Education

PhD in pharmaceutical/medical/physical/maths/engineering sciences

Tools

Phoenix WinNonlin

NLME

NONMEM

R

Python

MATLAB

Job description

Department: DMPK and Modelling Sciences

Location: (Måløv)

Your impact begins here

As a Pharmacokinetics and Pharmacodynamics (PKPD) Senior Principal Scientist, you will shape how translational modelling supports decisions across drug discovery and development. You will set direction for PKPD strategies, connect preclinical evidence with human safety and efficacy, and help interdisciplinary teams progress a diverse research portfolio. Your scientific leadership will strengthen project decisions from early research through clinical development and regulatory submission.

What you’ll bring

• A PhD in pharmaceutical, medical, physical, mathematical or engineering sciences, or another relevant discipline, combined with substantial pharmaceutical industry experience.
• Ideally, at least ten years of relevant experience in the pharmaceutical or biotechnology industry.
• Strong knowledge and hands-on experience in PKPD, quantitative systems pharmacology and/or physiologically based pharmacokinetic modelling.
• Experience developing mechanistic models, or combinations of mechanistic and empirical models, to represent biological or other natural processes.
• Practical experience with pharmacokinetic and modelling software such as Phoenix WinNonlin/NLME, NONMEM or an equivalent platform, and with analytical tools such as R, Python or MATLAB.
• Strong communication and stakeholder management skills, with the ability to influence decisions and collaborate across scientific disciplines.

Useful, but not essential: Experience with machine-learning workflows, managing external service providers, or supporting due diligence within physiologically based pharmacokinetic and pharmacokinetic/pharmacodynamic modelling.

What you’ll do

• Set the direction for translational PKPD screening and mechanistic modelling across different molecular formats, working with research, non-clinical and clinical stakeholders.
• Design preclinical PKPD/pharmacodynamic studies, interpret the results and communicate conclusions that support project decisions.
• Build mathematical models and run simulations of human PKPD using in-house in vitro and animal data, together with relevant literature.
• Guide project teams on preclinical study design, dose setting for toxicity studies, first-in-human dose selection and clinical trial design.
• Contribute scientific input to regulatory interactions and documents, including Investigational New Drug applications, Investigational Medicinal Product Dossiers and New Drug Applications.
• Advance scientific capabilities in mechanistic modelling and PKPD, solve complex problems and mentor fellow scientists.

Who you’ll work with

You will join one of two closely connected PKPD teams within DMPK and Modelling Sciences. Together, the teams advance the use of quantitative systems pharmacology, physiologically based pharmacokinetic modelling and PKPD modelling across the research and development value chain.

Your closest collaborators will include in vivo pharmacologists, in vitro biologists, clinical modelling scientists, toxicologists, clinicians and regulatory affairs specialists. The area is part of Global Research within Research & Development and works with global discovery and development colleagues, project teams and external partners.

What you can expect here

You can expect a scientifically ambitious environment where knowledge-sharing and collaboration are part of the everyday work. You will have room to build your scientific and personal capabilities while contributing expertise that informs preclinical studies, first-in-human trials, clinical development and regulatory submissions. The role offers broad exposure across therapeutic areas and across the development pathway, from early research to submission.

Salary:

For this role, the Annual Base Salary ranges from 847,000 to 1,245,100 (DK), corresponding to the level of the position. The confirmed JL9 pay table lists these as the annual minimum and maximum values, but the source does not state the currency explicitly.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits:

The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy. The salary and benefits wording follows the approved pay-transparency section in Job Ad Guidelines.

For further information, Line Hollesen Schefe, Manager, Non-clinical PKPD and PBPK, at [phone].

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.