Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - Durham
Posted Date: Aug 28 2024
GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and advanced technologies, such as functional genomics and AI/ML.
We have an exciting opportunity at GSK for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting oncology therapeutic area as part of the global Clinical Pharmacology Modelling and Simulation (CPMS) department. GSK provides a supportive environment for scientists who are aspiring to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence.
As an Associate Director, CPMS, you will be part of a science driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You'll have the opportunity to work on small molecules, biologics, and antibody drug conjugates in the Oncology therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.
Responsibilities include:
- Planning, conducting and reporting 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.
- 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.
- Writing or reviewing clinical pharmacology components of regulatory documents and responses to ensure GSK products are rapidly and efficiently approved with optimum labelling.
- Implementing best practices, trends, and lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline.
- Interacting 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.
Basic Qualifications:
- A doctorate (PharmD, PhD, MD) 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.
- 2+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM, Monolix, R or SAS.
- 2+ years of experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards.
Preferred Qualifications:
- 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.
- 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.
- Passion for quantitative clinical pharmacology and desire to innovate for better outcomes.
- Prior experience in Oncology Research and Development is a plus.
- 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.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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