VP, Clinical Pharmacology & Pharmacometrics, Systems and Tools

WISE Campaign; City Of London; Hybrid; GBP 130,000 - 160,000; Full time

Job summary

A global pharmaceutical company is seeking a VP to lead Clinical Pharmacology & Pharmacometrics Systems. The ideal candidate has over 15 years of experience in clinical pharmacology, proven leadership in drug development, and proficiency in modeling software. This role requires a collaborative approach to influence stakeholders and ensure quality support for drug lifecycle management. On-site presence is required 2 to 3 days a week in the UK.

Qualifications

• 15+ years’ experience in clinical pharmacology or pharmacometrics.
• Experience with modeling and simulation software.
• Direct line management experience in a pharmaceutical context.

Responsibilities

• Lead a team in clinical pharmacology research.
• Ensure high quality delivery of pharmacology support.
• Collaborate with cross-functional teams on drug development.

Skills

Clinical Pharmacology

Pharmacokinetics

Pharmacodynamics

Modeling and Simulation

Statistical Analysis

Leadership

Education

PhD in Clinical Pharmacology or related field

Tools

NONMEM

R

Python

SAS

Job description

Overview

Are you a clinical pharmacology leader keen to be part of an innovation hub which will lead a global team in advancing clinical pharmacology and pharmacometrics systems, tools, and standards to optimize drug development and lifecycle management for transformative medicines? If so, this VP level career opportunity at GSK is worth consideration.

The Career Opportunity: As the VP, Head, Clinical Pharmacology & Pharmacometrics Systems & Tools, you will lead a team of scientists with extensive expertise in clinical pharmacology, pharmacokinetics, pharmacodynamics, and modelling and simulation. The team enables decisions from target to patient by collaborating with teams to quantitatively interpret pharmacology, physiology, pharmacokinetics, and exposure-response to optimize value for patients and payers. This position will provide overall oversight, direction and leadership to the function which is accountable for advanced technical, therapeutic, and product development support to the Infectious Diseases, ViiV and Global Health portfolio and assets in life cycle management.

The VP, Head of Clinical Pharmacology & Pharmacometrics Systems & Tools will lead efforts to establish standardized, reproducible, and quality-assured practices across R&D. You will ensure the development and maintenance of an optimal and adaptable framework for supporting drug development by applying systems engineering principles to pharmacokinetic (PK) systems, and pharmacodynamic (PD) modeling and simulation. This involves collaborating with therapy area teams to integrate tools, systems, and processes that enable data-driven decisions on dosing, trial design, disease progression, and regulatory submissions for medicines and vaccines. In addition, the VP, Head Pharmacometrics Systems, & Tools, oversees post-marketing Clinical Pharmacology Modelling and Simulation (CPMS) activities.

Key Responsibilities

• Accountable for the high quality, timely delivery of all aspects of Clinical Pharmacology support to the portfolio.
• Influence the delivery and alignment of clinical pharmacology function with peer groups across the TA CPMS groups leading the relationship with Regulatory (internal), Biostatistics, DMPK, Clinical, Imaging, Clinical Biomarker, and Research Units.
• Responsibility for appropriate operational resource management and oversight of global resource.
• Support Modelling Practices, processes and procedures to support drug development programs.
• Ensuring tools and standards are in place to enable PK/PD data analysis to gain insights into drug behaviour, dosing regimens, and variability in response across patient populations.
• Ensuring the systems and tools are in place internally or externally, to create and validate pharmacometric models in a standardized and reproducible traceable manner
• Working closely with Rus (research units), clinical, regulatory, and statistical teams to integrate standardized pharmacometric insights into trial design and regulatory submissions.
• Identifying and resolving technical issues within systems/tools and suggesting continuous improvement initiatives and standardization of methods.
• Generate reports, presentations, and other documents to effectively communicate modelling results to various stakeholders.
• Guide and mentor junior pharmacometricians or engineers.
• Keeping abreast of the latest advancements in pharmacometric methodologies and relevant regulations.

Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (Stevenage or London HQ); or US (Upper Providence, PA or Waltham, MA.)

Basic Qualifications

• PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, Pharmacy, Pharmacology, Mathematics, Statistics, Engineering, or Bioinformatics.
• 15+ years\' experience in clinical pharmacology, pharmacometrics/modeling and simulation in the global pharmaceutical industry, with a focus on clinical drug development and regulatory submissions.
• Experience in pharmacometrics, including population PK/PD modelling, exposure-response analysis, and disease progression modelling.
• Experience with modelling and simulation software such as NONMEM, R, Monolix, Phoenix NLME, SAS, Python
• Direct line management experience
• Background in statistical methodologies relevant to pharmacometric analysis
• Experience with regulations and guidelines for pharmacometric analyses, including those from the FDA, EMA, and ICH.

Preferred Qualifications

• Excellent communication, collaboration, and interpersonal skills.
• Ability to work collaboratively with dynamic cross-functional teams and influence stakeholders at all levels.
• QSP experience
• Ability to analyse complex data, identify issues, and develop effective solutions.
• Experience with systems engineering principles or other relevant technical areas.

#LI-GSK

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK\'s compliance to all federal and state US Transparency requirements.