Clinical Pharmacology Modelling & Simulation Role at GlaxoSmithKline
A new position has come up in our Clinical Pharmacology Modelling and
Simulation Group (CPMS) at our Greater London site. This is an excellent role
to use quantitative clinical pharmacology to accelerate the delivery of new
medicines to patients, by enhancing drug development efficiency and business
decision quality. The work directly supports our mission to help our patients
do more, feel better and live longer.
The clinical PK/PD modeler will provide technical, therapeutic, and product
development support for GlaxoSmithKline projects across all therapeutic areas.
Individuals will ensure the optimal application of Clinical Pharmacokinetic
(PK), Pharmacodynamic (PD), and Modelling & Simulation (MS) principles towards
efficient drug development, risk management, and product registration.
Responsibilities generally commence at pre-clinical candidate selection and
continue through product lifecycle management.
Principle accountabilities include both modelling/simulation activities and
clinical pharmacology support:
* Plan, execute and report translational drug-disease modelling,
exposure-response analysis, simulation-based trial design and population
clinical pharmacology
* Contribute to clinical program design, trial protocols, analysis plans,
study reports and regulatory submissions
* Apply innovative methods such as longitudinal exposure-response
analysis, model-based meta-analysis and item-response analysis to improve data
use and trial efficiency
* Present strategy and defend outcome of model-based approaches to
internal governance boards and regulatory agencies
* Promote model-informed drug discovery and development through external
collaboration, journal publication and conference presentation
Basic Qualifications/Competencies:
* A doctorate relevant to Quantitative Clinical Pharmacology, and
experience in using modelling/simulation to solve practical problems in
industry or academia
* Proven skills in PK/PD and longitudinal disease modelling; and
verifiable proficiency in pharmacometric tools NONMEM, Monolix, R or SAS
* 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
and adapt to changing business needs by prioritising multiple tasks
Preferred Qualifications:
* Experience in the design, analysis, interpretation and reporting of
Clinical PK and PK/PD studies.
* Experience or demonstrated aptitude in the application of clinical PK
and PK/PD to the drug development process.
* Knowledge of pharmacology, biology, drug metabolism, biopharmaceutics,
regulatory affairs, therapeutics and commercialization such that he/she can
assist in managing these interfaces and ensure that CPMS input meets their
needs.
Why GSK?
Our values and expectations are at the heart of everything we do and form an
important part of our culture. These include Patient focus, Transparency,
Respect, Integrity along with Courage, Accountability, Development, and
Teamwork. As GSK focuses on our values and expectations and a culture of
innovation, performance, and trust, the successful candidate will demonstrate
the following capabilities:
* Operating at pace and agile decision-making - using evidence and
applying judgement to balance pace, rigour and risk.
* Committed to delivering high quality results, overcoming challenges,
focusing on what matters, execution.
* Continuously looking for opportunities to learn, build skills and share
learning.
* Sustaining energy and well-being
* Building strong relationships and collaboration, honest and open
conversations.
* Budgeting and cost-consciousness
At GSK, we develop therapies of various modalities for a broad range of
indications. As a member of a global department with diverse expertise, you
will enjoy a highly supportive environment for scientific innovation, business
impact and professional growth. This position is open for application till
Wednesday 5th August 2019. Interested persons are encouraged to apply online
https://jobs.gsk.com/en-gb/jobs/230574?lang=en-us&previousLocale=en-GB.
Chao Chen
Clinical Pharmacology Modelling & Simulation
GlaxoSmithKline R&D
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