• Contribute as Core Project Team member for selected projects
• Responsible for DMPK, in vivo efficacy, and pharmacology activities and strategies from early Research to First-in-human studies and beyond, through regulatory submissions, and eventually post marketing for assigned project(s)
• Lead translational development activities for ongoing or planned preclinical studies (including pharmacokinetic evaluation, reporting, delivery and archiving of quality final study report)
• Manage translational pharmacokinetics, PBPK and PK/PD modelling and simulation (e.g. human anticipated dose, safety margin predictions)
• Work closely on a day-to-day basis with key stakeholders in Research, Development, and Technical Operations to strategize and execute DMPK and nonclinical studies efficiently and with high quality
• Prepare and/or review nonclinical/pharmacological sections of internal documents, briefing books and regulatory submission documents (e.g. IB, IND, briefing books, NDA and other regulatory documents) as well as attend regulatory meetings
• Ensure that documentation is appropriately archived and available to internal and external stakeholders as required
• Verify consistency between nonclinical and clinical documents
• Actively prepare, review and publish scientific papers and abstracts
• Coach and develop DMPK scientists in the group

• A PhD/PharmD or equivalent experience in DMPK, metabolism, drug-drug interactions, early formulation, pharmacokinetics, in vivo efficacy studies, experience in anti-infectives would be beneficial
• Extensive experience (minimum 15 years) in the field of DMPK and shown ability to lead multiple program to the clinic, in the pharmaceutical industry
• Experience in preparing and/or reviewing clinical and non-clinical pharmacology sections of regulatory submission documents (e.g. IB, IND, Briefing Books, NDA and other regulatory documents) as well as attending regulatory meetings
• Direct experience in designing, conducting and interpreting PK and in vivo efficacy (PK/PD) studies and translation from preclinical to clinical studies, direct experience with the nonclinical development of anti-infectives (antibiotics & antifungals) would be an advantage
• Hands-on experience in PK and PK/PD analysis
• Experience with the management of external contractors
• Ability to plan, organize and manage multiple projects simultaneously with proactive, critical analysis of problems, taking appropriate actions for resolution
• Ability to work both independently and collaboratively in a team environment
• Fluency in English is required; proficiency in other languages is an advantage

Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on inspiring, cross-functional projects in an engaging working environment.  We strongly believe that every employee can make an impact and is vital to our success.  
If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application. Additional information can be found on our website www.basilea.com.