Principal DMPK Scientist/DMPK LeadBasilea • Allschwil, CH
Principal DMPK Scientist / DMPK Lead
Basilea • Allschwil, CH
Vor 8 Tagen
StellenbeschreibungContribute 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
We are looking for...
- ....a highly motivated Principal DMPK Scientist / DMPK Lead for our Development department.
Your tasks
Your profile
Why us?
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 .
About us
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 150 employees. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX : BSLN).
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Principal DMPK ScientistDMPK Lead • Allschwil, CH
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