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We are looking for a motivated and committed Clinical Science Enabler (CSE) for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 12 month assignment with the option to extend.
The Clinical Science Enabler (CSE) is a highly skilled professional with extensive experience in clinical pharmacology. The CSE works in tandem with the clinical pharmacologists and other cross-functional teams (PDRD, Bioanalytical team, M&S, Data Science, Operations) to support drug development projects across all phases, from early to late-stage. Depending on your experience, seniority, and capabilities, you may be responsible for selected specific tasks or multiple activities.
You will be responsible for the overall planning, management, data evaluation, and reporting of clinical pharmacology studies, as well as supporting the clinical pharmacology aspects of patient studies. You will also support project tasks such as combining clinical study data to support dose selection, assisting clinical pharmacologists in preparing documents for waiver requests, and summarizing data for briefing packages and regulatory submissions representing Clinical Pharmacology in relevant meetings.
In your role you will interact with both internal and/or external functions to support clinical studies, ensuring regulatory compliance, and providing high-quality scientific and strategic support. You will drive the clinical pharmacology contribution and serve as an expert in your domain, capable of training, mentoring, and coaching others.
The CSE is hands-on in integrating quantitative and qualitative data to inform decision-making and ensuring the successful execution of clinical studies. This often involves evaluating data across multiple studies to provide comprehensive insights. This role involves leading the implementation of innovative solutions, working closely with external partners, and ensuring that clinical pharmacology data are robust and regulatory-compliant. The CSE applies high scientific and ethical standards to define the pharmacokinetic (PK), pharmacodynamic (PD), and biomarker characteristics of investigational drugs, supporting regulatory submissions and product labeling. Additionally, the CSE leverages advanced data visualization tools to facilitate data-driven decision-making and streamline processes within a clinical study or across different studies.
Tasks
* 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.
* 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) modeling 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.
Must Haves
* 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.
Nice to Haves
* 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.
Are you interested? Don't hesitate and send us your complete application documents online today.
We will also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!
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