Director, Quantitative Clinical Pharmacologist

Director Quantitative Clinical Pharmacologist

GSK has an inspiring ambition: by uniting science technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system human genetics and advanced technologies such as functional genomics and AI/ML.

Job Purpose:

We have an exciting opportunity at GSK for a highly innovative Quantitative Clinical Pharmacologist to join our team supporting infectious disease area. GSK provides a supportive environment for scientists who are aspiring to learn to contribute and to make impact on business decisions through innovation expertise and influence.

You will be part of a science driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. Youll have the opportunity to work on both small molecules and biologics in the Vaccines and Infectious Disease therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.

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 an efficient clinical development program robust registration package and support life cycle management of an asset
• Provide optimal application of Clinical Pharmacokinetic (PK) Pharmacodynamic (PD) and Modeling & Simulation (MS) principles towards efficient drug development risk management and registration of compounds
• Play a central role in predicting human dose range characterizing exposure-response relationship and justifying dose recommendations for special populations.
• 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 strategy and discuss outcome of model-based approaches via interactions with governance boards and regulatory agencies
• Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy
• Promote model-informed drug discovery and development (MID3) through external collaboration journal publication and conference presentation.
• Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics
• Identify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the impact of DDI and special populations on PK where appropriate
• Write sections of drug development and registration documents such as clinical trial protocols and reports clinical investigator brochures and regulatory submission packages
• 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
• Innovate through working effectively with colleagues in the department and other matrix team members including statisticians biologists physicians and drug metabolism scientists

Why you

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Advanced Degree in Life science such as PhD PharmD or MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development.
• 5 years experience in clinical pharmacokinetics modelling & simulation and model-informed drug development including designing analysing and reporting clinical studies.
• 2 years experience of pharmacokinetic and pharmacodynamic principles and commonly applied models through previous projects in pharmaceutical industry roles or equivalent.
• 2 year experience working with common tools for quantitative clinical pharmacology such as NONMEM R WINNONLIN SIMCYP SAS and MATLAB through previous hands-on projects.
• 1 year experience with regulatory submission documents such as CTAs INDs NDAs MAAs and BLAs through direct involvement in regulatory submission activities in previous roles.
• 1 year 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:

• Knowledge of or ability to quickly learn the mechanism endpoints progression and treatments of diseases in infectious disease and other relevant therapy areas.
• Ability to communicate clearly and succinctly with the audience in mind both orally and in writing.
• 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*

#Hybrid*

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 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your inquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:

Director