Clinical Science Enabler (CSE)

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.

For our client F. Hoffmann - La Roche in Basel, we are looking for a motivated and reliable (m/f/d)

Clinical Science Enabler (CSE) 100%

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'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.
• 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.

Minimum Requirements:

• 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.
• Proficiency in Non-Compartmental Analysis (NCA) data analysis and interpretation and understanding of modeling principles, such as PBPK and popPK is essential.
• Experience in being the primary scientific responsible for writing final clinical study reports.

Nice to Have:

• Collaboration: Works effectively with team members and stakeholders, leveraging collective expertise.
• Embracing Diversity: Recognizes and values diverse perspectives and backgrounds, fostering an inclusive environment.
• Transparency: Maintains an open, humble and honest approach in all communications and actions.
• Open Sharing: Freely shares knowledge and findings to benefit the team and broader organization.
• Respect: Shows respect for colleagues irrespective of their grade, valuing their contributions.
• Accountability: Takes responsibility for actions, decisions, and results, encouraging the same in others.
• Reliability: Is dependable and consistently meets commitments and deadlines.

Start date: asap - latest: 01.04.2025

Planned duration: 6 months

Extension: possible

Home Office: 51% onsite, rest remote

Are you interested and would you like to seize this opportunity? Then we should definitely get to know each other! Simply click on "Apply now" and we look forward to receiving your complete application documents.