Apprenticeship training course

Clinical pharmacology scientist (integrated degree) (level 7)

Design, analyse, interpret and report clinical research and clinical trials.

• Qualification level: 7 ; Equivalent to master’s degree.
• Typical duration: 30 months
• Apprenticeship category: Health and science
• Maximum funding: £18,000 ; Maximum amount government will fund ; for apprenticeship training.
• Also known as:
  • Clinical pharmacokineticist
  • Clinical pharmacologist
  • Clinical pharmacology scientist
  • Quantitative clinical pharmacologist
• Skills:
  Skills an apprentice will learn

  • Dose determination - Calculate safe and efficacious human dose predictions (amount and schedule) from pharmacokinetic and toxicokinetics pre-clinical data using quantitative pharmacology methods (e.g. by allometry or physiologically based modelling) - Calculate recommended safe dose for first administration to humans based on pre-clinical data - Make predictions regarding viability/safety of additional dose levels and the likelihood of the effectiveness of a dose reduction strategy relative to maintaining and appropriate therapeutic window - Make recommendations about appropriate trial progression strategies (e.g. dose escalation) - Select and interpret data from a range of relevant sources (e.g. in silico models, biochemistry tests) in order to determine suitable doses for specific populations
  • Study design and delivery - Perform robust data reviews, including appropriate extrapolation from available knowledge and data, and the use of appropriate techniques to determine the potential for clinically relevant drug-drug interactions - Design efficient, safe, scientifically robust and feasible study protocols and support the design of bespoke clinical pharmacology development plans. Design should consider preclinical data and the impact of external factors (e.g. characteristics of the drug, budgetary, competitive landscape) and use appropriate powering, estimation, modelling and adaptive approaches where applicable. - Optimise study assessments (e.g. the type and timing of pharmacokinetic sampling, biomarkers and other assessments) taking into account both study needs and subject well-being, and including appropriate assessment criteria (e.g. interim and final) for analysis - Consider and propose methods (e.g. physiologically based pharmacokinetic modelling) alternative to clinical studies when appropriate - Contribute to the design and execution of go-no-go decisions
  • Study reporting and documentation - Write flexible and robust protocols - Make relevant contributions to clinical study reports - Interpret data and contextualise results (Interim and Final)
  • The appropriate use of statistics - Interpret statistical results appropriately (e.g. when summarising study outcomes) - Use appropriate software and graphical exploration to perform data analysis (e.g. exposure response, exposure safety) - Apply appropriate statistical techniques when analysing and summarising study outcomes, with support from statisticians where necessary
  • Interpretation of clinical study results - Contribute to analysis plans that describe how data will be analysed, summarised and graphically displayed - Select and apply the most appropriate method of data visualisation and analysis - Interpret data during study delivery for any interim decision points and for final study reporting discussions and conclusions; - Interpret the collated output from across multiple clinical studies
  • Critical evaluation and decision making - Contextualise results based on other internal and external information - Demonstrate aptitude in integrating information from a range of sources and critically evaluate it - Identify potential gaps in the clinical pharmacology understanding of a new molecular or biological entity - Identify the implications and making appropriate decisions (e.g. about study design and timing)
  • Legal and regulatory principles - Complete the required clinical pharmacology components of clinical trial application and a licensing application - Contribute to writing the drug label - Develop and write relevant components of regulatory documents (e.g. investigator brochure, protocol, informed consent document) - Interpret questions and feedback from regulatory, ethics and other review bodies and formulate appropriately detailed and clear responses - Data protection and confidentiality requirements and avoid breaches
  • Effective communication - Communicate effectively about their work and/or the work of their team to specialist and non-specialist audiences (e.g. oral presentation, protocols, consent forms and scientific reports) - Write scientific and technical documents that clearly convey interpretation and impact of findings - Discuss work constructively and objectively with internal and external stakeholders
  • Study management - Assess risks to delivering a protocol for the clinical pharmacology package and formulate mitigation plans - Redact, relabel and reference public domain case studies to avoid confidentiality breaches
  • Learning and development - Research, critique and assess new techniques and methodologies - Listen to learners to assess their understanding and adapt techniques to their needs, using ethical and safe practices when mentoring, coaching and training others

Full information on Clinical pharmacology scientist (integrated degree) (level 7) is available from the Institute for Apprenticeships and Technical Education.

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