Directeur d'expérience en certification at Demers Beaulne overseeing audit strategies and managing team performance in a hybrid setting with professional development opportunities.
GS
Hybrid Director, Oncology Clinical Pharmacology, Modeling and Simulation
Posted 2 days ago
About the role
- Director of Oncology Clinical Pharmacology at GSK focusing on modeling and simulation. Drives development strategies and collaborates on innovative oncology therapies to improve patient outcomes.
Responsibilities
- Defining and executing model-based development strategies for oncology projects
- Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection, and population PK modelling
- Applying innovative methods such as drug-disease modeling, longitudinal exposure-response analysis, model-based meta-analysis, quantitative systems pharmacology and AI/ML informed analyses to enhance data use and trial efficiency
- Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
- Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
- Write or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)
- Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline
- Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level
- Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation
- Work across matrix teams to innovate in methodologies, design efficiencies and create value
Requirements
- A PhD in Quantitative Clinical Pharmacology and Pharmacometrics (e.g., pharmacology, engineering or statistics) or relevant Life Sciences discipline, and experience in using modelling/simulation to solve practical problems in industry or academia.
- A PharmD or Master degree in the same disciplines with an additional 4 years of relevant experience may be considered.
- 5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM or R
- 3+ years of experience in planning, performing, and reporting analysis of clinical data per industry and regulatory standards
- Expertise in applications of AI/ML in Clinical Pharmacology and Pharmacometric analyses with innovative methodologies and efficiency applications.
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
- annual bonus
- eligibility for share based long term incentive program
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