GSK

biopharma

DirectorClinicalPharmacology

$188–188k United Kingdom; United States FULL TIME Remote Friendly
The Brief

“Director Clinical Pharmacology at GSK. Skills: Model-Informed Drug Development (MIDD), Clinical Pharmacology, Modelling & Simulation, Quantitative Medicine. Lead the end‑to‑end application of MIDD across the drug development lifecycle—from first‑in‑human studies through filing and lifecycle management. Provide clinical pharmacology strategy and evidence‑generation input”

What You'll Achieve.

de risk and accelerate RIIRU programs; faster development; optimal dosing; stronger regulatory positioning; timely approvals; optimal labelling; accelerate patient access to novel therapies; expand therapeutic indications of marketed drugs

Industry & Context.

biopharma
Problems you'll solve

solve practical problems; sound judgement in complex situations

What They're Looking For.

Must Have

PhD in life sciences or related discipline, MD, or PharmD, with experience in clinical pharmacology, modelling and simulation in pharmaceutical research and development., Significant experience in clinical pharmacology, modelling/simulation and drug development to solve practical problems in the pharmaceutical industry., Experience in pharmacometrics and their application to clinical questions in drug development.

Nice to Have

Additional experience in respiratory and immunology would be beneficial., Demonstrated experience of collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results., Evidenced experience making sound judgement in complex situations and adapting to changing business needs by prioritizing multiple tasks., Experience working with senior stakeholders in a cross functional environment., Track record of implementation of Model-Informed Drug Discovery and Development (MIDD) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs., Drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.

What You'll Do.

Lead the end‑to‑end application of MIDD across the drug development lifecycle—from first‑in‑human studies through filing and lifecycle management

Provide clinical pharmacology strategy and evidence‑generation input

Develop and implement robust MIDD & ClinPharm evidence strategies to de risk and accelerate RIIRU programs

Aim for faster development

optimal dosing and stronger regulatory positioning across respiratory

neurodegeneration and emerging areas

Support business development opportunities

Draft and review clinical pharmacology regulatory content to support timely approvals and optimal labelling

Maintain up to date knowledge of FDA

PMDA and ICH expectations

Embed regulatory considerations and best practices into study design and MIDD strategies

Build network key functions such as AI/ML

computational biology and RWE to embed quantitative approaches into decision making at asset level

Raise GSK’s profile in MIDD

clinical pharmacology

QSP and AI/ML integration through publications

conference presentations and active participation in scientific and regulatory fora to influence method adoption and regulatory dialogue

How You'll Work.

Team & Collaboration

Build cross‑functional partnerships; Work closely with CPQM peers (digital medicine, translational imaging, MIDD specialists, mechanistic/systems modelling) and cross functional partners (biology, data science, computational biology, clinical, etc.); Maintain networks and share best practices in the CPMS community of practice; Build network key functions such as AI/ML, biomarkers, biostatistics, clinical operations, data science, computational biology and RWE to embed quantitative approaches into decision making at asset level; Demonstrated experience of collaboration in a multi-discipline team; Experience working with senior stakeholders in a cross functional environment

Communication Scope

effective communication

Process & Methodology

prioritizing multiple tasks

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