Director of Clinical Pharmacology Modeling and Simulation

3 days ago

Waltham MA United States GlaxoSmithKline Full time
Site Name: Durham Blackwell Street, Upper Providence, Waltham
Posted Date: Nov 13 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.

Job Purpose:

We have an exciting opportunity at GlaxoSmithKline (GSK) for a highly innovative Quantitative Clinical Pharmacologist to join our team supporting infectious disease area as part of the global department of Clinical Pharmacology Modelling & Simulation. GlaxoSmithKline 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 a Director of Clinical Pharmacology Modelling and Simulation (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 both small molecules and biologics in the Vaccines and Infectious Disease therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development program, robust registration package and support life cycle management of an asset.
  • Provide optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development, risk management, and registration of compounds.
  • Play a central role in predicting human dose range, characterizing exposure-response relationship and justifying dose recommendations for special populations.
  • Develop mathematical models to understand disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance.
  • Present strategy and discuss outcome of model-based approaches via interactions with governance boards and regulatory agencies.
  • Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy.
  • Promote model-informed drug discovery and development (MID3) through external collaboration, journal publication and conference presentation.
  • Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics.
  • Identify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the impact of DDI and special populations on PK where appropriate.
  • Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages.
  • Learn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application.
  • Innovate through working effectively with colleagues in the department and other matrix team members, including: statisticians, biologists, physicians and drug metabolism scientists.
Why you? Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Advanced Degree in Lifesciences such as PhD, PharmD or MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development.
  • 5 years + experience in clinical pharmacokinetics, modelling & simulation and model-informed drug development including designing, analysing and reporting clinical studies.
  • Experience of pharmacokinetic and pharmacodynamic principles and commonly applied models through previous projects in pharmaceutical industry roles or equivalent.
  • Experience working with common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, SIMCYP, SAS and MATLAB through previous hands-on projects.
  • Experience with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs through direct involvement in regulatory submission activities in previous roles.
  • Experience through previous roles in applying appropriate FDA and ICH guidelines in the design of clinical development plans and studies.
Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Demonstrated expertise in specific technical areas related to modelling and simulation, and/or the vaccines and infectious disease therapeutic area.
  • Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in infectious disease and other relevant therapy areas.
  • Ability to communicate clearly and succinctly with the audience in mind, both orally and in writing.
  • Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results.
  • Sound judgement, analytical mindset and problem-solving skills.
  • Ability to effectively multi-task and deliver results on time.
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