Quantitative Clinical Pharmacology / PKPD Lead - Belgium
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- The ideal candidate will have experience in the area of quantitative clinical pharmacology activities in either immunology or neuroscience, working in both early and late phases of clinical development, including life-cycle management.
- In collaboration with other disciplines, he/she will be accountable and responsible for leading and driving, for the assigned project(s), an integrated PK-PD strategy (safety and efficacy) from clinical candidate selection through life-cycle management, driving clinical pharmacology plans, dose and regimen selection.
- Specific aspects include transnational PK-PD understanding and modeling, effective integration and use of in silico, in vitro and in vivo preclinical data with mechanism-based models to anticipate the effects of new drugs in humans and transitional components.
- Development of clear quantitative go-no-go decisions as the molecule passes through key stages of development.
- In particular, he/she will ensure high quality input to Project Life-cycle Teams as well as safeguarding that the quantitative clinical pharmacology component of the assigned global clinical development programs/projects are of high quality, meet regulatory standards and are delivered according to agreed timings.
- Act as a QCP/PK-PD lead on assigned CRST and program/project teams, delivering Quantitative Clinical Pharmacology Strategic planning.
- In particular, ensure that clear strategic QCP/PK-PD direction and input is provided to study level plans, designs, dose selections, PK/PD measures, strategy, and where appropriate operational expertise.
- Responsible for design, analysis, interpretation and reporting of human pharmacology results and PK-PD results from non-human pharmacology studies.
- Developing/managing clinical pharmacology/M&S -related aspects of clinical trial/program budgets
- Participate in implementing Model Based Drug Development using quantitative approaches to address complex questions arising during drug development.
- In particular, integrating PK-PD knowledge on an ongoing project basis. Accountable and responsible for assigned protocol synopsis and study report content.
- As appropriate, being the overall early lead for the assigned project.
- Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD data are generated and analyzed including population PK, PK-PD modeling and simulation, meta-analysis etc., to support the project progression.
- Providing recommendations for clinical doses and dosing algorithms to the clinical and Development teams and, for the project of competence, leading the quantitative clinical pharmacology contributions to all regulatory documents, leads and contributes to the writing and reviewing responses to regulatory queries.
- May provide quantitative clinical pharmacology/pk-pd expertise to discovery and due diligence activities
- Expanding and maintaining key networks of external thought/opinion/academic leaders, as well as alliances with partners from the pharmaceutical industry, ensuring publication of key clinical pharmacology studies in international, peer reviewed journals, and presentations at international scientific meetings of relevance
- Knowledge of Clinical Pharmacology and the application of Modeling & Simulation
- Able to understand clinical effects, pharmacological, physiological and biochemical understanding
- Knowledge of basic pharmacology in vivo/in vitro models
- Able to understand/Interpret safety/pharmacology/toxicology data
- Experience in the assigned therapeutic area and with surrogate marker identification and application
- Experience in managing/delivering PK/PD modeling activities
- Experience in managing/delivering PBPK, population PK and IVIVE
- Understanding of mechanism-based drug interactions/In vivo/in vitro models
- General knowledge of Biopharmaceutics/Biostatistics/Pharmacogenomics
- Sufficient Knowledge of phases of Drug development
- Able to communicate quantitative clinical pharmacology PK/PD core activities at a project and clinical team level in a manner that promotes productive relationships.
- Ability effectively contribute to interdisciplinary team meetings and, able to effectively leading sub-teams (e.g. QCP) motivating others in matrix/departmental environment.
- Able to represent function and our company at regulatory meetings
- Understand drug development bridging strategies
- Ability to anticipate program needs and problem-solve, sharing critical data within the team and the line and proactively proposing solutions,
- Working in a matrix team based environment being the initiator of the assigned part of development plans and studies
- Scientific expertise recognized internally and externally
- The candidates should have demonstrated experience (through examples) of participating and contributing to the development and execution of the clinical plan, with specific input and expertise in the clinical pharmacology components, including regulatory aspects (e.g briefing documents, MHRA meetings, pediatric plans, INDs, regulatory responses for labeling activities)
- He/ She is able to attend regulatory meetings representing function and company with minimal coaching.
- A strong understanding of pharmacodynamic and transnational methods, experimental medicine tools, regulatory requirements, PK/PD, DMPK, population pharmacokinetic-pharmacodynamic modelling and simulation.
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