Clinical Pharmacology Lead
Mundipharma
Cambridge, UK
21h ago

About Us

Since the global network was founded in 1952 by a family of physicians, the Mundipharma network has always challenged conventional wisdom, and we expect the same from our employees.

If you crave the freedom to think and work in new ways, then this is the place for you. Our flat organization allows you to make decisions and deliver results fast, which makes this an exhilarating and exciting place to work regardless of your role.

Job Description

  • Provides direction & strategy for clinical pharmacological activities across all therapeutic areas to support the Mundipharma development and established brand portfolio.
  • Ensures best practice and effective management of CROs supporting clinical pharmacology activities, biomarker development and pharmacometric programmes.
  • Delivers comprehensive clinical pharmacological technical expetise and leadership to support an expanding portfolio of early development projects, through input into clinical study design & interpretation, biomarker strategies and PK / PD modelling and simulation.
  • Duties & Responsibilities

  • Supports Asset Teams with design, analysis and evaluation recommendations on all clinical studies, with a key focus on translational aspects, biomarker development and PK / PD modelling and simulation predictions as required.
  • Coordinates effective clinical pharmacology trials, including study design, conduct and reporting, in relation to pharmacokinetics, bioanalytical analysis to rapidly de-risk programs.
  • Leads discussions on translational aspects for pre-clinical and early clinical studies (supporting the three pillars of drug development, e.
  • g. drug exposure, target engagement and functional modulation).

  • Enables close collaboration on the identification of novel therapeutic concepts.
  • Embeds best practice with clinical pharmacology and translational research practices, processes and systems, through maintaining a current awareness of latest developments and industry benchmarking.
  • Supports asset teams on dose and dosing regimen predictions (pre-IND) and dosing recommendations preclinically and design of clinical studies to enable appropriate exploration and understanding of dose response
  • Ensure appropriate PK parameter analysis from all clinical studies, author reports to summarise and interpret data analysis for inclusion in the Clinical Study Report, Regulatory briefing documents etc.
  • Manages partnership with relevant service providers (CROs), including but not limited to e.g. M&S services, optimising relationships, ensuring deliverables are timely and accurate, monitoring and acting on quality and performance KPIs.
  • Ensures analysis and predictive PK and PK / PD simulation software is optimal and all relevant Clinical Pharmacology SOPs are up to date and fit-for-purpose.
  • Explores early assessment of biomarkers to guide e.g. asset development and patient stratification, with the ultimate goal of enabling personalized medicine.
  • Works effectively with other functions within R&D to efficiently achieve high quality results and generate a high functioning team ethos.
  • Who we're looking for

  • Collaborative leadership skills, able to leverage the talent across R&D & cross-functional Asset Teams to drive clear decision making and cross-functional alignment.
  • Strong strategic thinker, with effective communication skills to influence the wider organisation with respect to the role of pharmacometrics in development products.
  • Strong analytical and technical skills, with knowledge and experience of the utility of modelling and simulation to impact study design, both Phase 2 and pivotal clinical studies, and the application of pharmacometrics to drug development.
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