We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our global Clinical Pharmacology Modelling and Simulation (CPMS) department. While this is a U.S. based position remote work option is available for the right candidate.
The Director of Quantitative Clinical Pharmacology
will use Pharmacometrics knowledge and Project Leadership skills to accelerate the delivery of new medicines to patients by enhancing development program efficiency and business decision quality, from preclinical candidate selection to regulatory approval and beyond.Key Responsibilities:
In this role, you will have principal accountabilities that include both modelling/simulation activities and clinical pharmacology leadership:
Why you? Basic Qualifications:
- Planning, conducting and reporting translational drug-disease modelling, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modelling
- Applying innovative methods such as longitudinal exposure-response analysis, model-based meta-analysis and quantitative systems pharmacology to enhance data use and trial efficiency
- 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)
- Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
- 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
We are looking for professionals with these required skills to achieve our goals:
- A doctorate relevant to Quantitative Clinical Pharmacology and Pharmacometrics (e.g. pharmacology, engineering or statistics)
- Experience in using modelling/simulation to solve practical problems in industry or academia
- Proven skills in mechanistic PKPD and longitudinal disease modelling
- Proficiency in pharmacometrics tools such as NONMEM, Monolix, R or SAS
- Experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards
- Experience working in a large matrixed environment
- Project team leadership
If you have the following characteristics, it would be a plus:
- Experience in model-informed drug development for Vaccines and/or Infectious Disease indications
- Passion for quantitative clinical pharmacology and desire to innovate for better outcome
- Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design and endpoints
- Demonstrated aptitude for productive collaboration in a multi-discipline team, with effective communication and taking personal accountability for timely delivery of results
- Clear evidence of ability to make sound judgement in complex situations, think independently and adapt to changing business needs by prioritizing multiple tasks
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
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