design PK elements of Phase 2 / 3 clinical studies, and manage the modeling (PK, PK / PD) strategy Responsible for co-authoring and preparing clinical documentation including (but not limited to) clinical study outline, clinical study protocols, clinical study or modeling reports (including exposure-
response analysis), IBs, INDs, and NDAs Represent clinical pharmacology in regulatory interactions with Health Authorities Pro-
actively identify potential project hurdles & suggest solutions or contingency plans Select and work closely with external vendors and consultants supporting non-
clinical (DMPK), clinical studies Function as Core Project Team member for defined projects Lead clinical pharmacology activities from pre-
IND / Phase 1 to late phase studies, through regulatory submissions, and eventually post marketing for assigned projects Work closely on a day-
to-day basis with key stakeholders in development, research and toxicology to strategize and execute clinical pharmacology studies efficiently and with high quality Support pharmacology for ongoing or planned preclinical, clinical and toxicology studies (including pharmacokinetic evaluation, reporting, delivery and archiving of quality final study report) Translational pharmacokinetics, PBPK and PK / PD modeling and simulation (e.
g. human anticipated dose, safety margin predictions) Preparing and / or reviewing 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 attending regulatory meetings Ensure that documentation is appropriately archived and available to internal and external stakeholders as required.
Actively preparing, reviewing and publishing scientific papers and abstracts Qualifications and Experience Background (BSc or Masters) in Pharmacology, PhD or equivalent experience in clinical pharmacology, pharmacokinetics, and / or pharmacometrics >
8 years industrial experiences in clinical pharmacology, preferably in oncology Experience in conducting and interpreting clinical pharmacology studies and translation from preclinical to clinical studies Experience leading clin Pharm from Ph 1 through to Ph 3 studies Experience with translational PK, PBPK and PK / PD Experience in preparing and / or reviewing clinical pharmacology sections of regulatory submission documents (e.
g. IB, IND, Briefing Books, NDA and other regulatory documents) as well as attending regulatory meetings Ability to work in a highly collaborative matrix environment with excellent organizational and communication skills Ability to handle and oversee multiple tasks in parallel Attention to quality and details Highly motivated, proactive Fluent spoken and written English Relevant working / residency permit or Swiss / EU-Citizenship required.