Are you a scientist with a flair for mathematical modelling and knowledge of pharmacology, biology or physiology? Are you passionate about Pharmacokinetics and Pharmacodynamics (PKPD) and using model-informed drug development for linking the preclinical data to human safety and efficacy? If you're ready to drive innovation and make a meaningful impact in the field of PKPD as well as in progressing Novo Nordisk’s innovative portfolio, we have an exciting opportunity waiting for you! Come and join our Development PKPD department. The position As a PKPD Specialist, you will be involved in a great variety of tasks related to PK and PKPD assessment, modelling and animal to human translation.
You will be supporting interdisciplinary project teams across the value chain from early non-clinical development through clinical development and to final submission.
Your key stakeholders will include scientists across various scientific areas, e.g.
in vivo pharmacologists, in vitro biologists, QSP modelling scientists, toxicologists, clinicians and regulatory affairs specialists.
Some of your main responsibilities will include: 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 Qualifications To succeed in the role, we expect you to have: 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 Ph D) 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 Win Nonlin/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 such as Chat GPT and Co Pilot is preferred Experience in managing external service providers is an advantage Experience with Due diligence evaluation within PBPK and PKPD is an advantage On a personal level, you have excellent communication and stakeholder management skills and the ability to effectively interact with colleagues with a variety of backgrounds.
You work independently and effectively within cross-functional teams and with external partners to drive research initiatives and achieve project goals.
At the Novo Nordisk Specialist level, you are expected to have +5 years of experience from the pharmaceutical industry.
We are open to candidates with diverse levels of experience and seniority.
The responsibilities of the position will be adjusted to match the candidate's qualifications and experience. 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.
We foster knowledge-sharing, collaboration and a supportive environment where individuals contribute with their expertise and collectively drives the implementation of translational mathematical modelling across the value chain.
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.
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. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change.
We drive it.
We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.
We embrace the spirit of experimentation, striving for excellence without fixating on perfection.
We never shy away from opportunities to develop, we seize them.
From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information please contact Line Hollesen Schefe, Manager Development PKPD, on +45-3077 6009.
Deadline 23 February 2025. Please note that we will only conduct interviews after the application deadline has passed. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.
We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.
We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.
Together, we’re life changing.
Reklame
Development Pkpd Specialist, Måløv
Free
Development Pkpd Specialist, Måløv
Denmark, Denmark, Måløv,
Udgivet February 4, 2025
Beskrivelse
Joboplysninger
⇐ Tidligere arbejde |
Næste job ⇒ |
Kontakt arbejdsgiver
Arbejdsgiver info

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com.
This page isn't intended for discussions about products. As such, postings or comments that contain product discussions may be removed. This page is for discussions about Novo Nordisk and its subsidiaries and the initiatives and projects we are involved in. While we welcome everyone to make comments, we reserve the right to remove those that are off-topic, abusive or intended to spam.
Any questions specific to products should be made to your healthcare professional. If you wish to file an adverse drug reaction please contact Novo Nordisk's office in the country you live in:
https://www.novonordisk.com/contact-us/find-local-information.html
For other customer complaints, please contact us here:
https://www.novonordisk.com/contact-us.html
Please keep in mind that Novo Nordisk A/S and its subsidiaries work within a highly regulated industries. Therefore, comments that pertain to legal matters or regulatory issues may be removed.
Comments contained on this site come from members of the public, and do not necessarily reflect the views of Novo Nordisk A/S. Novo Nordisk A/S does not endorse or approve any content added by other LinkedIn users.
Learn more about our privacy disclaimer and community guidelines here http://www.novonordisk.com/communityguidelines