Pharmaceutical PKPD Specialist

2 days ago

Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

About the Role

We are seeking a skilled scientist to join our Development PKPD department at Novo Nordisk A/S.

The ideal candidate will have a strong background in mathematical modelling and pharmacology, with experience in using model-informed drug development for linking preclinical data to human safety and efficacy.

Main Responsibilities:

  • Setting the direction and drive the execution of the translational PK and PK/PD strategy across different molecular formats and in alignment with key non-clinical and clinical stakeholders to ensure efficient project progression.
  • Designing preclinical PK and PK/PD studies, interpreting and reporting data.
  • Building mathematical models and performing simulations of human PK and PD based on in-house in vitro and animal data as well as literature data on relevant compounds to inform project decisions.
  • Guiding projects within topics related to e.g. preclinical study design, toxicity studies dose setting as well as first in human clinical dose setting and trial design.
  • Interacting with regulatory authorities, including providing written input to regulatory documents (e.g. IND, IMPD, NDA).
  • Demonstrating ability to drive and maintain state of the art competencies and know-how within PK/PD, as well as being an innovator impacting the R&D value chain.
  • Independently solving unique and complex problems that have a broad impact on the business.

Requirements

To succeed in this role, you should have:

  • A Ph.D. within Pharmaceuticals, Medical, Physics, Math or Engineering sciences, or other disciplines or equivalent pharmaceutical industry experience and ideally have 5+ years of relevant experience (post PhD) within the pharmaceutical/biotech industry.
  • Strong understanding of PK/PD theory, modelling methodology, data interpretation and translational science methodologies.
  • Outstanding ability to identify challenges, develop strategies, and translate them into actionable work packages.
  • Solid experience with and understanding of pharmacokinetics and modelling software (e.g. Phoenix WinNonlin/NLME, NONMEM or equivalent), as well as software for data processing and analysis (e.g. R, Python, Matlab).
  • General digital literacy across generative AI platforms is preferred.
  • Experience in managing external service providers is an advantage.
  • Experience with Due diligence evaluation within PBPK and PKPD is an advantage.

About the Department

You will join a dynamic team of dedicated and highly motivated PKPD scientists and have great opportunity to develop personal and scientific skills.

In Development PKPD we support projects with pharmacokinetic and pharmacodynamic evaluation using a variety of modelling and simulation tools from early non-clinical development to submission. Our evaluation is essential to secure project progress.

Personal Qualities

As a key member of our Development PKPD team, you must possess excellent communication skills and be able to collaborate effectively with colleagues and stakeholders at all levels.

You will be working in a fast-paced environment and must be able to manage multiple tasks and priorities while maintaining a high level of accuracy and attention to detail.

Your exceptional problem-solving skills and analytical thinking will enable you to tackle complex challenges and drive innovation in the field of PKPD.

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