Development PKPD Specialist

The position

As a Development PKPD Specialist, you will be involved in a great variety of tasks related to PK and PKPD assessment, modelling and translation. You will be supporting interdisciplinary project teams across the value chain from early non-clinical development to submission. You will join a dynamic team that fosters knowledge-sharing, collaboration and a supportive environment where individuals contribute with their expertise and collectively drives the implementation of mathematical modelling across the value chain. Your key stakeholders will include preclinical and clinical scientists across various scientific areas, as well as Development and Non-clinical project teams. You will also interact with scientists using machine learning, data science and human centric in vitro methods. Some of your main responsibilities will include: Setting the direction and drive the execution of the translational PK and PK/PD strategy across modalities and in alignment with key stakeholders to ensure efficient project progression Designing preclinical PK and PK/PD studies, collecting and reporting data 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. preclinical study designs, 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 this 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 exceptional communication and stakeholder management skills and the ability to effectively interact with colleagues with a variety of backgrounds. You work effectively within cross-functional teams and with external partners to drive research initiatives and achieve project goals. 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. 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.