Senior Scientist Clinical Pharmacology Pharmacokinetics

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Freedom, Indiana

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Fri, 26 Mar 2021 23:59:59 GMT

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Job Title: Senior Scientist – Clinical Pharmacology & Pharmacokinetics Job Description: Senior Scientist Clinical Pharmacology and PharmacokineticsDo you have a passion for science and developing new medicines? If you are an experienced pharmacokineticist or clinical pharmacologist with a genuine interest in translational medicine and clinical pharmacology, and you are looking for an opportunity to make a significant personal impact, this job may be your perfect match. You will join a small, but highly competent and agile team of multinational scientists with global responsibility for pharmacokinetics, PK/PD modelling, and clinical pharmacology, covering all Ferrings therapeutic areas. As the Translational Medicine & Clinical Pharmacology representative on global teams, you will work in close collaboration with other disciplines (including early research PK, pharmacology, toxicology, pharmaceutical sciences, medical functions, medical writing, clinical operations and regulatory affairs), supporting the translational and clinical development of promising drug candidates. You can also look forward to being part of a very positive, informal and open environment where we share knowledge and support each other. Broad translational and clinical pharmacology development responsibilities As Senior Scientist in the Translational Medicine & Clinical Pharmacology department you will apply your knowledge and innovative mindset to projects at all stages of development, from late discovery to global clinical development, regulatory submission and life cycle management. Your primary tasks will be to: – Be responsible for the overall clinical PK of assigned drug development candidates – Develop strategies related to clinical pharmacology and PK/PD aspects of drug development – Contribute to Translational Development Plans and Clinical Development Plans – Collaborate with colleagues in Global Drug Discovery to ensure alignment between pre-clinical and clinical PK/PD activities – Support dose predictions for first-in-human trials and dose selection for later clinical trials – Provide expertise in the design and evaluation/interpretation of clinical pharmacology trials e.g. SAD, MAD, renal & hepatic impairment, TQT, DDI, BA/BE – Plan, perform and report PK and PK/PD data analyses (all phases of development) – Author clinical pharmacology and PK/PD sections of documents including clinical trial protocols and reports, Investigator Brochures, INDs, NDAs, briefing packages, labelling proposals, etc. – Contribute to due diligence activities – Stay updated in the clinical pharmacology and pharmacokinetics scientific field and relevant regulatory guidelines – Represent the line function in cross-functional teams and in connection with scientific, clinical and regulatory activities Solid experience within the area of pharmacokinetics and clinical pharmacology As this position is a key function within Translational Medicine & Clinical Pharmacology in Ferring Pharmaceuticals, we expect you to be an experienced and motivated scientist with the following qualifications: – A university degree in pharmaceutical sciences, bioscience, or medicine – A strong scientific profile (PhD preferred) with a solid basis in PK, ADME principles and data analysis – Minimum 5-10 years of industry or equivalent experience in clinical pharmacology and/or PK – A genuine understanding of regulatory guidelines related to clinical pharmacology and PK – Experience with regulatory authority interactions – Experience with Phoenix WinNonlin, NLME or other PK analysis and modelling tools As a person, you are a proactive problem solver and a strong team player. You know how to ensure quality and keep track of the important details, also when being responsible for different types of projects at the same time. As you will work as part of a global organisation you must be proficient at tailoring your message to your audience in English to make yourself understood also by people with different scientific skillsets and vocabulary. Furthermore, you enjoy working in a multicultural environment in a changing and evolving company. Your new team You will join a small team of highly skilled scientists within pharmacokinetics, modelling & simulation, and clinical pharmacology, initially at Ferring IPC in restad, Copenhagen and later this year at Ferrings new research center on the resund waterfront close to Copenhagen Airport. Together with the Medical Section we are part of the Department of Translational Medicine & Clinical Pharmacology. We work in an open, informal atmosphere characterized by mutual respect, knowledge sharing, and helpfulness. Contact and application Please send your application and CV no later than 22 March 2021. If you have any questions you are very welcome to contact Christiane Hesse, Senior Medical Director Clinical Pharmacology, at +45 2878 7122 or . Please note that we review applications on an on-going basis and close the process when we find the right match the sooner you apply the better are your chances. Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists breaking new land to help people live better lives all around the globe. As a privately-owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the worlds leading company within reproductive medicine and maternal health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at Location: Ferring Denmark