Director Clinical Pharmacology

Director Clinical Pharmacology

The Department of Clinical Pharmacology Modelling & Simulation Respiratory and Inflammation (CPMS R&I) at GSK is recruiting a director-level Clinical Pharmacologist.

This role is based in UK or US with remote working or placement at other European GSK sites possible for the right candidate.

Job Purpose:

The Director Clinical Pharmacology sits within the newly established Clinical Pharmacology and Quantitative Medicine (CPQM) organisation which aims to be a centre of excellence in ModelInformed Drug Development (MIDD) by integrating clinical pharmacology digital medicine translational imaging and mechanistic/systems modelling.

You will lead the endtoend application of MIDD across the drug development lifecyclefrom firstinhuman studies through filing and lifecycle managementand provide clinical pharmacology strategy and evidencegeneration input. This is an opportunity to join a highly regarded highimpact team with a strong publication track record reporting directly to the Respiratory Immunology & Inflammation Research Unit (RIIRU).

Main responsibilities:

• Design & Execute Model Informed and Clinical Pharmacology strategies:

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 inflammation neurodegeneration and emerging areas and support business development opportunities.

• Ensure robust ways of working and regulatory ready evidence

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 and best practices into study design and MIDD strategies.

• Build crossfunctional 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 strong networks and share best practices in the CPMS community of practice. Build strong 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.

• External engagement & scientific leadership

Raise GSKs 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

Why you

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

*LI-GSK#

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

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Director