[Remote] Clinical Pharmacology Director
Note: The job is a remote job and is open to candidates in USA. Elemed is a science-led, clinical-stage biotech developing a new generation of biologics for haematologic disease. They are seeking a Senior Clinical Pharmacology Consultant to lead the clinical pharmacology efforts for first-in-human dosing and regulatory submissions, working closely with the development team.ResponsibilitiesLead dose selection and justification for the first-in-human studyBuild and run the PK/PD, exposure-response and population PK modelling behind the dosing rationaleAuthor the clinical pharmacology sections of the IND, protocol and Investigator's BrochureAct as the in-house subject matter expert on dosing strategy across development discussionsSupport FDA interactions as requiredSkillsSenior, hands-on clinical pharmacologist (Senior Director level and up, or ED / VP-calibre operating as a consultant) who does the modelling and writing personally rather than directing a teamDeep clinical pharmacology background in biologics, specifically monoclonal antibodies, with a track record taking programmes from preclinical into first-in-human, including dose setting and ClinPharm submission contentToxicology / nonclinical experienceOncology or haematology backgroundCompany OverviewWe're on a mission to accelerate the availability of healthcare products through the power of people. Because healthcare touches us all. It was founded in 2014, and is headquartered in Zürich, -, CH, with a workforce of 2-10 employees. Its website is https://elemed.eu.