- Setting the direction and drive the execution of the PBPK and PK/PD strategy across modalities, including small molecule projects and in alignment with key stakeholders to ensure efficient project progression
- Building mathematical models and performing simulations of human PK and PD based on in vitro and animal data as well as literature data on relevant compounds
- Informing and guiding projects within topics related to e.g. first in human clinical trial design, CYP and transporter-mediated Drug-Drug Interactions (DDIs), organ impairment, pediatric pharmacokinetics, food-effect, and bioequivalence
- 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 PBPK and PK/PD, as well as being an innovator impacting the R&D value chain
- Working across several projects and supporting colleagues in the department with your specialist competencies and more general PBPK and PK/PD skills
- Independently solving unique and complex problems that have a broad impact on the business
- Solid experience with PBPK and translational science methodologies
- Experience in integration of in vitro and in vivo ADME, pharmacokinetics, pharmacology, and biology understanding into mathematical modelling approaches
- Understanding of PK/PD theory and modelling methodology and data interpretation
- Outstanding ability to identify challenges, develop strategies, and translate them into actionable work packages
- Extensive expertise and programming skills with PBPK and PK/PD modelling software (e.g. SimCyp, PK-Sim, GastroPlus, Phoenix WinNonlin/NLME, NONMEM), as well as software for data processing and analysis (e.g. R, Python)
- General digital literacy across generative AI platforms such as ChatGPT and CoPilot is preferred
- Experience in managing external service providers is an advantage
- Experience with Due diligence evaluation within PBPK and PKPD is an advantage
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Principal Scientist - Måløv, Danmark - Novo Nordisk A/S
Beskrivelse
Do you want to be part of our pioneering journey to advance the way we use mathematical modelling to inform and guide drug discovery and development? Are you an experienced scientist with strong mathematical modelling skills and strong expertise within physiologically based pharmacokinetics (PBPK)? If so, apply today and join the Development PKPD department in a permanent position within the Research and Early Development organization at Novo Nordisk
The position
In this role, you will utilize your proficiency within cutting-edge PBPK modelling and simulation across therapeutic areas. This requires efficient collaboration and communication with subject matter experts. You will be part of a growing team that collectively drives the implementation of mathematical modelling and engages with scientists from preclinical to late clinical development. The focus is to support and integrate in vitro and in vivo ADME, pharmacokinetics (PK), pharmacodynamic (PD), and biology understanding into mathematical modelling approaches.
Some of your main responsibilities will include:
Qualifications
You hold a Ph.D. within Life Science, Health, Medical, Physics, Math or Engineering sciences, or other disciplines related to Drug Metabolism and Pharmacokinetics (DMPK) and ideally have 10+ years of relevant experience (post PhD), of which at least 5 years are within the pharmaceutical/biotech industry in pharmacometrics or mathematical modelling and simulation. You have a proven track record within disciplines related to DMPK and an excellent understanding of theory and principles of advanced mathematical modelling and simulation and your ability to translate these tools into actionable insights is exceptional.
To succeed in the role, you have:
As a person, you are open-minded, keen to learn new skills and able to communicate with experts in other areas. You have exceptional communication and stakeholder management skills. Furthermore, you have demonstrated experience and a keen interest in mentoring and sharing knowledge with junior scientists and colleagues. In addition, you have excellent written and oral communication skills in English.
All candidates with relevant qualifications interested in the role are encouraged to apply. Your application might be considered for a different level of the same position.
About the department
In Development PKPD you will have dedicated and highly motivated colleagues supporting 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.
In preclinical development we are responsible for predicting human PK and PK/PD, setting doses for preclinical studies and for first in human trials, and reporting toxicokinetics to GLP, as well as providing input to regulatory documents (e.g. IND, IMPD, NDA). During clinical development, we conduct the interim PK evaluation during early phase 1 trials and collaborate with clinical pharmacologists and clinical pharmacometrics to support later clinical pharmacology studies (e.g. Drug-Drug-Interaction, renal and hepatic impairment) as well as addressing PBPK and PK/PD related questions and issues as they may arise. The models inform and support drug discovery, development and regulatory interactions.
The department is anchored within Global Drug Discovery (GDD) in Research & Early Development (R&ED) and in our daily work, we have a close collaboration with all parts of the global Discovery and Development organization, global project teams as well as external collaborators.
