At a Glance
- Tasks: Join a dynamic team to innovate in drug development for Infectious Diseases and Oncology.
- Company: GSK, a leading global healthcare company focused on innovation.
- Benefits: Competitive salary, supportive environment, and opportunities for professional growth.
- Other info: Collaborate with top scientists and contribute to groundbreaking research.
- Why this job: Make a real impact in healthcare by applying your expertise in quantitative clinical pharmacology.
- Qualifications: Advanced degree in life sciences and 5+ years in clinical pharmacokinetics and modelling.
We have an exciting opportunity at GSK for a highly innovative Quantitative Clinical Pharmacologist to join our team supporting the Infectious Disease area as well as important Oncology life cycle management programs. 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. You'll have the opportunity to work on both small molecules and biologics in the Vaccines, Infectious Disease and Oncology 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- 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.
- 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.
- Pharmacometric experience for Oncology assets including ADCs.
- 2 years + experience of pharmacokinetic and pharmacodynamic principles and commonly applied models through previous projects in pharmaceutical industry roles or equivalent.
- 1 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.
- Demonstrated expertise in specific technical areas related to modelling and simulation, and/or the vaccines and infectious disease therapeutic area.
- 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.
Director, Quantitative Clinical Pharmacologist in London employer: WISE Campaign
GSK is an exceptional employer that fosters a collaborative and innovative work culture, particularly for those in the field of quantitative clinical pharmacology. With a strong emphasis on employee growth and development, GSK offers unique opportunities to engage in impactful research within the Infectious Disease and Oncology therapeutic areas, all while being part of a supportive team at their state-of-the-art facilities in Upper Providence, Pennsylvania, and Stevenage, UK. Employees benefit from competitive salaries, comprehensive benefits, and the chance to contribute to groundbreaking advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Quantitative Clinical Pharmacologist in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the field of quantitative clinical pharmacology on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA and ICH guidelines. Be ready to discuss how you’ve applied these in past projects, as this will show you're not just book-smart but also practical.
✨Tip Number 3
Showcase your modelling and simulation skills during interviews. Bring examples of your work with tools like NONMEM or R, and be prepared to explain your thought process behind your models.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team.
We think you need these skills to ace Director, Quantitative Clinical Pharmacologist in London
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the role of Director, Quantitative Clinical Pharmacologist. Highlight your relevant experience in clinical pharmacokinetics and modelling & simulation, as well as any specific projects that align with the responsibilities mentioned in the job description.
Showcase Your Skills:Don’t just list your qualifications; demonstrate how your skills in pharmacometric analysis and regulatory submissions have made a difference in your previous roles. Use specific examples to illustrate your expertise and how it can benefit our team at GSK.
Be Clear and Concise:When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless it's necessary. We want to see your ability to communicate complex ideas simply, which is crucial for this role.
Apply Through Our Website:We encourage you to apply directly through our website. This ensures your application gets to the right people quickly and allows us to review your credentials efficiently. Plus, it’s the best way to stay updated on your application status!
How to prepare for a job interview at WISE Campaign
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical pharmacokinetics, pharmacodynamics, and modelling & simulation principles. Be ready to discuss how you've applied these in past projects, especially in the context of oncology or infectious diseases.
✨Showcase Your Experience
Prepare to talk about your hands-on experience with tools like NONMEM, R, and MATLAB. Have specific examples ready that demonstrate how you've used these tools to solve real-world problems in drug development.
✨Understand the Guidelines
Familiarise yourself with FDA and ICH guidelines relevant to clinical studies. Be prepared to discuss how you've incorporated these guidelines into your previous work, particularly in designing clinical development plans.
✨Communicate Effectively
Practice articulating complex ideas clearly and succinctly. Whether it's discussing model-based approaches or presenting to governance boards, being able to communicate your thoughts effectively is key to making a strong impression.
