A clinical stage biopharmaceutical company is strengthening its Clinical Pharmacology and Early Clinical Development function with a senior scientist who can carry quantitative work from study design through to regulatory submission. The group sits close to the decision makers, so modelling and exposure analyses shape dose selection and protocol design directly rather than being commissioned after the fact.

The position suits someone who wants breadth. The remit spans study design input, hands on analysis, oversight of outsourced bioanalytical work and the writing that turns all of it into protocols, reports and submissions. It also carries technical leadership within a small team.

Key Responsibilities

• Own clinical pharmacology deliverables across assigned programmes, working autonomously in alignment with the head of the function

• Act as technical reference point for the group, supporting and mentoring less experienced scientists

• Conduct non compartmental, population and physiologically based pharmacokinetic analyses

• Deliver exposure response and cardiac safety analyses in support of dose selection and study design

• Contribute to model informed drug development through exploratory modelling, trial simulation and the design of modelling strategies at programme level

• Oversee outsourced bioanalytical activity, covering provider selection, method validation review, scheduling and budget

• Produce tables, figures and listings and technical reports of submission quality

• Apply reproducible programming and version control practice across analysis datasets

• Contribute to clinical protocols, development plans, study reports and peer reviewed publications

• Prepare clinical pharmacology content for regulatory interactions with EMA and FDA alongside Regulatory Affairs

• Partner with clinical development, biostatistics and data management to ensure analyses are decision ready

Essential Experience

• Postgraduate qualification, ideally to PhD level, in pharmacy, pharmacology, medicine, biology, biotechnology or a related discipline

• Minimum of 3 years in clinical research with a clear clinical pharmacology focus

• Demonstrated proficiency in pharmacometric software such as NONMEM, Monolix or PK Sim

• Advanced programming capability in R, with SAS or equivalent

• Experience contributing to protocols, study reports or regulatory documentation

• Fluent written and spoken English

Desirable Experience

• Exposure to first in human and early phase study conduct

• Physiologically based pharmacokinetic modelling

• Track record of peer reviewed publication

• Experience managing external analytical providers

• Additional programming languages such as Python