Quantitative Clinical Pharmacology Lead - Gene therapy

Posted 16 September 2022
Job type Permanent
Contact NameJack Watterson Burnell

Job description

Quantitative Clinical Pharmacology Lead

I am currently working with a Global Pharmaceutical company who are looking to strengthen their current QP team by brining on a Quantitative Clinical pharmacology lead. They are seeking a well-established individual within the field who is able to strategically lead the QP group.

Our client is looking for someone who can demonstrate experience in strategically leading clinical pharmacology input for large or small molecules into development programs from pre-FIH to life-cycle management.

You will contribute by:

· Leading and scoping the quantitative clinical pharmacology activities in assigned project(s) to drive further Early and Late Clinical Development, working with other functional experts to create a clinical development plan.

· In collaboration with other disciplines, he/she will be accountable and responsible for leading and driving, for the assigned project(s), an integrated PK-PD strategy (safety and efficacy) from clinical candidate selection through life-cycle management, driving dose and regimen selection and drive the implementation of model informed drug development, including trial design and execution.

· As a key member of quantitative discovery and development (QDD) and development sciences, you will foster and facilitate a collaborative working environment between non-clinical safety, DMPK, bioanalysis, non-clinical PK-PD, modelling and simulation to leverage key scientific and strategic input into projects.

· From a development science perspective, you may also be responsible to ensure a clear development science strategy is formed and lead a matrix team covering; QCP, Modelling and Simulation, DMPK, Toxicology and Bioanalytical ensuring clear deliverables and key milestones are achieved and drive project decisions. He/she will also ensure high quality and robust input is given into development teams.
Experience Required
· Educated to PharmD or PhD (or equivalent) with either relevant academic or industrial experience.
· You will have demonstrated experience (through examples) of participating and contributing to the development and execution of the clinical plan, with specific input and expertise in the clinical pharmacology components, including regulatory aspects (e.g briefing documents, MHRA meetings, INDs, regulatory responses for labelling activities), and is able to attend regulatory meetings representing function with minimal coaching.
· A strong understanding of pharmacodynamic and translational methods, experimental medicine tools, regulatory requirements, PK/PD, DMPK, population pharmacokinetic-pharmacodynamic modelling and simulation.

The Ending
If you want to find out more about this exciting opportunity, please get in contact with me at:

Email: jack.watterson-burnell@biotalent.com

Phone: 020 3960 1276

BioTalent Ltd are acting as an employment agency in relation to this opportunity.