Director of Fleet and Facilities overseeing operational oversight for fleet and facilities at Summit Utilities, a growing natural gas utility company.
About the role
- Director of CPMS Oncology at GSK focusing on delivering quantitative excellence for innovative therapies. Overseeing model-informed drug discovery and development strategies for oncology projects.
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
Requirements
- A PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) 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.
- Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancers.
- Ability to keep up-to-date with and propose the implementation of new modeling approaches to inform drug development.
- Experience with AI/ML tools and applications in pharmacometrics is a plus.
- Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.
- Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks.
- Experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards.
- Passion for quantitative clinical pharmacology and desire to innovate for better outcome.
- Prior experience in Oncology Research and Development is a plus.
- Experience working with senior stakeholders in a cross functional environment.
- Excellent interpersonal skills with strong oral/written communication and presentation skills.
- Strong track record of implementation of Model-Informed Drug Discovery and Development (MID3) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs.
Benefits
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
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