***Please note that depending on levels of experience we are open to interviewing candidates at the Director, Associate Director or Manager level***
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 position ideally based in Upper Providence PA, a remote work option is available for the right candidate.
This is an excellent opportunity where you will use Quantitative Clinical Pharmacology and Pharmacometrics knowledge 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 include, but are not limited to:
In this role, you will have principal accountabilities that include both modelling/simulation activities and clinical pharmacology leadership:
- 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 (PharmD, PhD, MD) relevant to Quantitative Clinical Pharmacology and Pharmacometrics (e.g., pharmacology, engineering or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia
- Proven skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM, Monolix, R or SAS
- 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
If you have the following characteristics, it would be a plus:
- Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design
- 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
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression, prevention and treatments of Infectious Disease
- Prior experience in Vaccine Research and Development is a plus
- Experience and/or aptitude with managing teams and developing staff (for Director/Senior Director levels)
- Experience working with senior stakeholders in a cross functional environment
- 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
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 geneticsscience; 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 diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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