Switzerland
Posted 2 years ago
Key responsibilities
- Manage finance, budget and timelines related to assigned clinical pharmacology and pharmacometrics activities
- Design, plan, manage (oversight of contractors when applicable) and report the pharmacometrics
- studies (Non-Compartmental PK analysis, Population PK, PK/PD, Exposure/Response, Probability
- of Target Attainment, PBPK, Modelling & Simulation) of DPI compounds in development
- Manage the clinical pharmacology and pharmacometrics part of assigned clinical studies
- Participate in the study design with regard to clinical pharmacology aspects
- Participate in the preparation of informed consent forms, clinical protocol, SAP and CSR,
- and other study-related documents
- Determine, implement and manage the PK or PK/PD data analyses and reporting according to GCPs and regulatory guidelines
- Contribute to the medical data review with regard to clinical pharmacology aspects (risk of drug-drug interactions and management of concomitant medications)
- Ensure adequate filing of pharmacometrics study documents in the e-TMF
- Be a member (as Clinical Pharmacologist) of one or more Clinical Study team(s)
- Manage outsourcing activities to an international network of CROs (Europe, Asia and America) or through academic collaborations (preparation of RFP, contractors selection, contracts review and budget negotiation)
- Contribute to the preparation of clinical pharmacology and pharmacometrics documentations to support the cross-functional activities (including PK chapters of regulatory documents
- Participate in external scientific communications (publications, poster and oral presentations, and press releases)
- Contribute to in/out licensing activities and external fund-raising activities
Your profile
- PharmD, PhD or an equivalent degree in pharmacokinetics, pharmacology, life sciences or a related discipline with a minimum of 5 years experience in clinical pharmacology or pharmacometrics within Translational R&D
- Excellence knowledge of GCP, GCLP, GLP and ICH guidelines
- Knowledge of Regulatory Affairs (EMA, FDA…) is a plus
- First experience in project management
- Strong communication & presentation skills
- Very good communication & influencing skills (oral and written)
- Fluency in English (both oral and written)
- Strong team player, looking to drive further projects and innovation
Job Features
| Job Category | CLINICAL DEVELOPMENT |