Reference #: 404012 Site Name: USA - Massachusetts - Waltham, GSK HQ, Stevenage, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence Posted Date: Sep 6 2024

We have an exciting opportunity at GSK for a highly motivated and experienced director-level quantitative clinical pharmacologist to join our team supporting the oncology therapeutic area as part of the global Clinical Pharmacology Modelling and Simulation (CPMS) department.  If you are energized by leveraging your clinical pharmacology and pharmacometrics experience to accelerate the development of oncology therapeutics this role may be for you. Job Purpose

As a Director of Clinical Pharmacology Modelling and Simulation (CPMS) you will be part of a large science driven team delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You'll have the opportunity to work on a wide diversity of therapeutic modalities including small molecules, biologics, and antibody-drug-conjugates in the Oncology Therapeutic Area. CPMS responsibilities generally commence post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.

At GSK we are proud to combine both clinical pharmacology and modeling & simulation (M&S) accountabilities into one role aiming to bring the value of model-informed drug development to our R&D portfolio. GSK provides a supportive environment for scientists who are aspiring to learn, contribute and lead to make an impact on development decisions through innovation, expertise, and influence. 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 efficient clinical development programs and robust registration packages

Play a central role in predicting human dose range, characterizing exposure-response relationship and justifying dose recommendations for later studies and for special populations.

Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics

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 the CPMS strategy and discuss outcome of model-based approaches via interactions with project teams, governance boards and regulatory agencies

Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages

Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy

Advocate for the use of model-informed drug discovery and development (MID3) in teams and through external collaboration, journal publication and conference presentation.

Innovate through working effectively with colleagues in the department and other matrix team members, including: development team leaders, statisticians, biologists, physicians and drug metabolism scientists

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. Why you?Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:

Advanced training with a degree such as PhD, PharmD and MD in Pharmaceutical Sciences, (Bio)Engineering, Mathematics, Statistics, Medicine or related field

5+ years experience leveraging clinical pharmacology and modeling in drug development

5+ years experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models

5+  years of experience utilizing tools for quantitative clinical pharmacology such as NONMEM, Monolix, R, SAS and/or MATLAB

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:

Oncology drug development experience.

Solid experience with advanced pharmacometric approaches such as tumor size kinetics and joint models, or model-based meta-analysis, or adaptive dosing simulations, and/or mechanistic PKPD modeling

Experience in designing, analyzing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate

Familiarity with M&S contributions to regulatory submission documents

Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology.

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 #LI-GSK*

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK? Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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