Clinical Science Enabler
vor 3 Wochen
Direct message the job poster from CTC Resourcing Solutions AG
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of both in vitro diagnostics and manufacturing and selling of several innovative drugs.
We are currently looking for an enthusiastic Clinical Science Enabler for a 12-month contract (with possibility of extension) based in Basel, Switzerland.
The perfect candidate should have solid knowledge and experience in clinical pharmacology science combined with hands-on expertise in quantitative-qualitative data analysis with a deep understanding of Clinical Regulatory.
Main Responsibilities:
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.
- 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.
- Utilize advanced data visualization tools and statistical software to facilitate data-driven decision-making and streamline processes within a study or across studies.
- Apply 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).
- Serve as an expert in your domain, capable of training, mentoring, and coaching others for clinical pharmacology support.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- 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.
- 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 modelling principles, such as PBPK and popPK is essential.
- Hands-on experience in modelling 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.
- Strong communication skills and proficiency in English is a must.
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.
Seniority levelMid-Senior level
Employment typeContract
Job functionScience
IndustriesPharmaceutical Manufacturing and Biotechnology Research
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