Development PKPD Specialist (Denmark, Måløv)

Jobbeskrivelse
Placering
Måløv, Denmark

Jobkategori
Research

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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 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 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

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
5 January 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.