Clinical Science Enabler (CSE) (m/f/d)

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• Clinical Studies: Responsible and accountable for the overall planning, management, data evaluation, and reporting of clinical pharmacology studies as an individual contributor, including the clinical pharmacology contribution for patient’s
  studies.
• Capacity Extension: Identify solutions for clinical study support through internal groups (e.g., PDRD, Bioanalytical team, M&S, Data Science, Operations) and manage external solutions through trustful relationships.
• Data Visualization: Utilize advanced data visualization tools and statistical software to facilitate data-driven decision-making and streamline processes within a study or across studies.
• Modeling (PBPK and popPK): Understanding and apply (if applicable) modelling techniques to support model-informed drug development (MIDD).
• Regulatory: Ensure regulatory compliance by integrating regulatory requirements into clinical studies and project workflows. Assist in and take hands-on authoring responsibility for the preparation and submission of regulatory documents, including the clinical pharmacology components of Investigators Brochure, IND, and NDA/BLA documentation, as well as materials for presentations, briefing packages, and responses to inquiries from health authorities. Ensure a deep understanding of data integration
  and interpretation for filing documents, presentations, and discussions, to effectively communicate clinical pharmacology findings and support regulatory submissions.
• Maintain up-to-date knowledge of regulatory guidelines and policies (i.e. GCP, ICH).
• Expertise and Training: Serve as an expert in your domain, capable of training, mentoring, and coaching others for clinical pharmacology support.

• A degree in a relevant scientific discipline (e.g., MSc, PharmD, PhD) in pharmaceutical sciences, clinical pharmacology, or a related field.
• Minimum of 4+ years of experience in clinical pharmacology science, with a proven track record of being responsible for the scientific aspects of clinical pharmacology study including protocol synopsis, protocol development, consent form, eCRF, and protocol amendments. In patient studies, lead all clinical pharmacology activities. Represent Clinical Pharmacology in Study Team Meetings.
• Extensive expertise in the evaluation and interpretation of clinical pharmacology data, including pharmacokinetics (PK), pharmacodynamics (PD), biomarkers, and safety, ensuring scientific and medical validity and consistency.
• Proficiency in Non-Compartmental Analysis (NCA) data analysis and interpretation and understanding of modeling principles, such as PBPK and popPK is essential. 
• Hands-on experience in modeling data analysis is a plus.
• Skilled in integrating quantitative and qualitative data to inform decision-making,implementing innovative solutions, and providing strategic and scientific insights across multiple studies to support the Clinical Pharmacologist Lead.
• Experience in being the primary scientific responsible for writing final clinical study reports 
• Experience in assisting in and taking hands-on authoring responsibility for the preparation and submission of regulatory documents, including the clinical pharmacology components of Investigator’s Brochure, IND, and NDA/BLA documentation, as well as materials for presentations, briefing packages, and responses to inquiries from health authorities.