Principal ADME Scientist - Late-Stage Discovery & Development

The position

As a Principal ADME Scientist in Development ADME, you will drive projects and be responsible for evaluation of ADME and DDI from late-stage discovery, throughout non-clinical and clinical development towards drug registration. This role entails a specific focus on drug metabolism within small molecule projects. Some of your main responsibilities will include: Designing, conducting, and managing in vitro, and in vivo studies to evaluate the drug metabolism and DDI profiles of drug candidates both in-house and at contract research organizations Informing and guiding projects within drug metabolism and DDI related topics e.g. risk assessment of drug metabolites, drug clearance pathways, CYP (Cytochrome P) and transporter-mediated DDIs Interacting with regulatory authorities, including providing written input to regulatory documents (e.g. Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), New Drug Application (NDA)) Champion innovation and new scientific initiatives for early and late-stage development programs by proactively reviewing literature and other technological advancements in the scientific area Providing strategy and information for Physiologically Based Pharmacokinetic modeling (PBPK) to support translation of in vitro ADME and DDI results Independently solving unique and complex problems that have a broad impact on the business Qualifications You hold a Ph.D. within pharmaceutical, life, health, or medical sciences, or equivalent pharmaceutical industry experience and ideally 10+ years of relevant experience within small molecule ADME and DDI in drug discovery and development in the pharmaceutical/biotech industry. You have an exceptional understanding of scientific and strategic principles of drug development. To succeed in the role, you have: Solid experience with use of LC-MS for structure identification of drug metabolites Solid experience with drug metabolism, ADME and DDI study conduct Demonstrated knowledge of interpretation and translation of result from in vitro and in vivo drug metabolism, ADME and DDI studies with small molecule drug candidates Outstanding ability to identify challenges, develop strategies, and translate them into relevant study designs Experience with due diligence evaluation within ADME and DDI is an advantage Experience with PBPK modelling and translational science is an advantage General digital literacy across generative AI platforms such as ChatGPT and CoPilot is preferred 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 and the ability to effectively interact with colleagues with a variety of backgrounds. 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. About the department In Development ADME we are responsible for evaluation of drug metabolism and excretion and DDI from late-stage discovery, throughout non-clinical and clinical development towards drug registration. We work with several stakeholders within R&D and conduct different types of ADME and DDI studies to support the drug safety evaluation and the drug label. Studies are conducted both at contract research organizations and in-house. You will be part of a team, which consist of scientists and laboratory technicians: all highly skilled and dedicated people working together in an open and scientifically challenging environment. We are openminded and value collaboration, scientific discussions, and knowledge sharing. 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 to manufacturing, marketing and sales – we’re all working to move the needle on patient care.