Director, Cardiovascular & Metabolic MIDD

GSK

Collegeville (PA)

Híbrido

USD 223.000 - 371.000

Tempo integral

Há 2 dias
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Benefícios oferecidos por esta vaga

Health insurance
Retirement benefits
Paid holidays
Paid caregiver/parental leave

Resumo da vaga

GSK is seeking a Director-level Clinical Pharmacologist to lead end-to-end Model-Informed Drug Development within CPQM and CPMS. You will guide pharmacology strategy across RIIRU, shaping clinical programs from first‑in‑human to lifecycle management.

You will collaborate with digital medicine, translational imaging, and data science teams to accelerate development, optimize dosing, and strengthen regulatory positioning for respiratory and inflammation therapies.

Qualificações

  • PhD, MD, or PharmD.
  • 8+ years of industry experience in clinical pharmacology, modelling/simulation and drug development.
  • Experience in pharmacometrics and its application to clinical questions in drug development.
  • Experience working with senior stakeholders in a cross functional environment.
  • Experience in Cardiovascular and Metabolic Diseases therapy areas.
  • Demonstrated experience of collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.
  • Experience implementing Model-Informed Drug Discovery and Development (MIDD) approaches to accelerate patient access to novel therapies.

Responsabilidades

  • Design & Execute Model Informed and Clinical Pharmacology strategies.
  • Develop and implement robust MIDD & ClinPharm evidence strategies to de risk and accelerate RIIRU programs.
  • Coordinate & Optimize CPMS activities across and above assets within RIIRU, ensuring consistency and alignment of global CPMS/CPQM priorities and senior leadership.
  • Ensure robust ways of working and regulatory ready evidence. Approve study designs, analyses, interpretation, reports and clinical pharmacology regulatory documents across RIIRU portfolio.
  • Draft and review clinical pharmacology regulatory content to support timely approvals and optimal labelling.
  • Maintain up to date knowledge of FDA, EMA, CDE, PMDA and ICH expectations and embed regulatory considerations into study design and MIDD strategies.
  • Build cross functional partnerships across CPQM expertise and CPMS community to embed quantitative approaches into decision making.
  • External engagement & scientific leadership: raise GSK’s profile in MIDD and AI/ML integration through publications and conferences.

Conhecimentos

Drug Design
Drug Development
Drug Discovery Process
Drug Discovery Research
Medication Safety
Molecular Modeling
Pharmaceutical Regulatory Compliance
Pharmaceutical Sciences
Pharmacodynamics
Pharmacokinetics
Pharmacology
Pharmacometrics
Pharmacovigilance
Study Design
Target Validation

Formação

PhD, MD, or PharmD

Descrição da vaga

GSK is seeking a Director-level Clinical Pharmacologist to lead end-to-end Model-Informed Drug Development within CPQM and CPMS. You will guide pharmacology strategy across RIIRU, shaping clinical programs from first‑in‑human to lifecycle management.

You will collaborate with digital medicine, translational imaging, and data science teams to accelerate development, optimize dosing, and strengthen regulatory positioning for respiratory and inflammation therapies.

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