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Clinical Science Enabler (CSE) (m/f/d), Basel
Location:
Job Category:
-
Job Reference:
924012TP_1739269812
Job Views:
5
Posted:
11.02.2025
Expiry Date:
28.03.2025
Job Description:
Clinical Science Enabler (CSE) (m/f/d) – Pharmacology / Clinical Regulatory / Data Evaluation / IND / GCP
Project: For our customer, a big pharmaceutical company in Basel, we are looking for a highly qualified Clinical Science Enabler (CSE) (m/f/d).
The perfect candidate should have solid knowledge and experience in clinical pharmacology science combined with hands-on expertise in quantitative-qualitative data analysis and a deep understanding of Clinical Regulatory. The candidate should show team spirit, respect, and inclusiveness in all interactions.
Tasks & Responsibilities:
1. 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 studies.
2. Capacity Extension: Identify solutions for clinical study support through internal groups and manage external solutions through trustful relationships.
3. 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.
4. Modeling (PBPK and popPK): Understand and apply modeling techniques to support model-informed drug development (MIDD).
5. 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.
6. Maintain up-to-date knowledge of regulatory guidelines and policies (i.e. GCP, ICH).
7. Expertise and Training: Serve as an expert in your domain, capable of training, mentoring, and coaching others for clinical pharmacology support.
Must Haves:
1. A degree in a relevant scientific discipline (e.g., MSc, PharmD, PhD) in pharmaceutical sciences, clinical pharmacology, or a related field.
2. 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 studies.
3. Extensive expertise in the evaluation and interpretation of clinical pharmacology data, including pharmacokinetics (PK), pharmacodynamics (PD), biomarkers, and safety.
4. Proficiency in Non-Compartmental Analysis (NCA) data analysis and interpretation and understanding of modeling principles, such as PBPK and popPK.
5. Skilled in integrating quantitative and qualitative data to inform decision-making and providing strategic and scientific insights across multiple studies.
6. Experience in assisting in and taking hands-on authoring responsibility for the preparation and submission of regulatory documents.
Nice to Have:
1. Collaboration: Works effectively with team members and stakeholders.
2. Embracing Diversity: Recognizes and values diverse perspectives and backgrounds.
3. Transparency: Maintains an open, humble, and honest approach in all communications and actions.
4. Open Sharing: Freely shares knowledge and findings to benefit the team and broader organization.
5. Respect: Shows respect for colleagues irrespective of their grade.
6. Accountability: Takes responsibility for actions, decisions, and results.
7. Reliability: Is dependable and consistently meets commitments and deadlines.
Reference Nr.:
924012TP
Role:
Clinical Science Enabler (CSE) (m/f/d)
Industrie:
Pharma
Workplace:
Basel
Pensum:
100%
Start:
ASAP
Duration:
12++
Deadline:
17.02.2025
If you are interested in this position, please send us your complete dossier.
If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information:
+41 41 760 77 01
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates, this is free of charge; also for Payroll, we do not charge you any additional fees.
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