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 :

Preferred Qualifications :

If you have the following characteristics it would be a plus :

#LI-GSK

#Hybrid

If you are based in Cambridge MA; Waltham MA; Rockville MD; or San Francisco CA the annual base salary for new hires in this position ranges $188100 to $313500. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the addition this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and paid caregiver / parental and medical leave. If salary ranges are not displayed in the job posting for a specific country the relevant compensation will be discussed during the recruitment process.

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.

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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

Key Skills

Fundraising,Management Experience,Coaching,Analysis Skills,Strategic Planning,Team Management,Budgeting,Leadership Experience,Mentoring,Public Speaking,negotiation,Supervising Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 188100 - 313500