Director, Oncology Clinical Pharmacology Modeling & Simulation

Job Purpose

We have an exciting opportunity at GSK for a highly motivated and experienced Director to join our team supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. This role combines both clinical pharmacology and modeling and simulation (M&S) accountabilities aiming to bring the value of model-informed drug development to our R&D portfolio, helping to inform and accelerate the development of innovative oncology therapies by ensuring they reach the right patients, at the right dose, and at the right time.

As a Director, CPMS Oncology, you will have the opportunity to work on small molecules, biologics, and/or antibody drug conjugates. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. GSK provides a supportive environment for scientists who are aspiring to learn, contribute and lead to making an impact on development decisions through innovation, expertise, and influence.

Hybrid setting: office presence for 2-3 days per week.

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 at study, indication and or program level, 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 PhD or MD in Pharmaceutical Sciences, (Bio)Engineering, Statistics, Medicine or related field. A PharmD or Master’s degree in the same disciplines with an additional 4 years of relevant experience may be considered.
• 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, or R.
• 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, model-based meta-analysis, 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 interaction and submission documents
• Knowledge / 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*

LI-Hybrid*

Skills

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