Senior Clinical Pharmacology Assessor

This is a full-time opportunity on a permanent basis.The role will be based in 10 South Colonnade Canary Wharf London E14 4PU.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

We are currently implementing a flexible hybrid way of working with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role this can flex up to 12 days a month with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly.

Who are we

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices underpinned by science and research.

The Clinical Pharmacology group assesses the pharmacokinetic and pharmacodynamic aspects of marketing authorisation applications Early Access to Medicines (EAMS) Innovative Licencing Pathway (ILAP) or clinical trial applications for medicinal products and amendments including those with new or complex issues and takes decisions regarding their suitability for approval.

The objective of the Healthcare Quality and Access portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It does this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access as well as ensuring compliance with regulations and standards.

The Innovative Medicines function delivers a risk-appropriate critical appraisal of quality safety and efficacy of innovative medicinal products determining whether a products benefits outweigh the risks. It aims to accelerate their route to market and to drive earlier patient access. Through this function the Agency is seen as a leader in facilitating early access to safe and innovative medicines attracting the life sciences sector and contributing to a positive patient experience and to the improvement of public-health outcomes.

Whats the role

Reporting to the Head of the Clinical Pharmacology Teamthis roleencompasses the evaluation of a range of chemical and biological products including new active substances at different stages of development.

The reports written and advice provided will be highly influential in initiating trials of new medicines and taking these through clinical development and/or allowing new medicines to be made widely available to patients.

The post offers career development and progression opportunities in line with our internal development programme.

Key responsibilities:

• You will assess the clinical pharmacology aspects of a range of medicinal products including the latest new drugs new formulations generics biosimilars and clinical trial products. Your scientific and professional expertise in pharmacokinetics and pharmacodynamics will be vital in this role as you join a multidisciplinary team including clinical non-clinical pharmaceutical/quality and statistical assessors.

• You will provide advice on aspects related to pharmacokinetics and pharmacodynamics to colleagues within the division.

• You will interact with colleagues from other regulatory agencies and you will present your considerations to UK multi-disciplinary expert advisory committees.

• You will be involved in the development of regulatory guidelines and the provision of scientific advice on drug development programmes.

Who are we looking for

Oursuccessful candidatewill:

• Hold a degree in life sciences including but not limited to pharmacy pharmacology medicine biochemistry etc.

• Experience in at least one of the following fields: pharmacokinetics pharmacodynamics biopharmaceutics and pharmacokinetic modelling (e.g. population pharmacokinetics physiologically based pharmacokinetic modelling). Experience to have been acquired within the pharmaceutical industry governmental departments or academia.

• Up-to-date specialist level of knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the clinical pharmacology aspects of human medicinal products.

• Sound knowledge of relevant legislation and regulatory procedures applicable to the licensing of human medicinal products.

• Evidence of applying scientific perspective to data evaluation and to advise others.

Person Specification:

Method of assessment:AApplication TTest IInterview PPresentation

Behaviour Criteria:

• Making effective decisions: Evidence of applying scientific perspective to data evaluation and to advise others. (A I)

• Communicating and influencing: Excellent written and verbal communication skills. Ability to communicate scientific concepts to experts and lay people. (A I)

• Managing a quality service: Ability to handlehigh throughput ofwork commensurate with experience and knowledge to meet required deadlines.(A I)

• Delivering at pace: Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome within the required timelines.(A I)

Experience Criteria:

• Experience in at least one of the following fields: pharmacokinetics pharmacodynamics biopharmaceutics and pharmacokinetic modelling (e.g. population pharmacokinetics physiologically based pharmacokinetic modelling). Experience to have been acquired within the pharmaceutical industry governmental departments or academia.(A I T)

• Up-to-date specialist level of knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the clinical pharmacology aspects of human medicinal products.(A I T)

• Sound knowledge of relevant legislation and regulatory procedures applicable to the licensing of human medicinal products.(A I)

Technical Criteria:

• Hold a degree in life sciences including but not limited to pharmacy pharmacology medicine biochemistry etc. (A)

If you would like to find out more about this fantastic opportunityplease read our Job Description and Person Specification!

Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description please contact

The selection process:

We use the Civil Service Success Profiles to assess our candidatesfind out more here.

• Online application form including questions based on theBehaviour Experience and Technical Success Profiles.Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind and our Hiring Managers will not be able to access your CV when reviewing your application.

• Test further information will be supplied when you reach this stage

• Interview which can include questions based on theBehaviour Experience Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications we will hold an initial sift based on the lead criteria of:your relevant specialist knowledge in one or more relevant scientific or technical areas or breadth of knowledge across a range of disciplines relevant to this position.

Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allowsufficienttime. You can view the competencies for this role in the job description.

Use of AI in Job Applications

Artificial Intelligence can be a useful tool to support your application however all examples and statements provided must be truthful factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others or generated by artificial intelligence as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see ourcandidate guidancefor more information on appropriate and inappropriate use.

If you require any disability related adjustments at any point during the process please contact as soon as possible.

Closing date:12^th May 2026

Shortlisting date: from 13^th May 2026

Interview date:week commencing 8th June 2026

If you need assistance applying for this role or have any other questionsplease contact

Candidates will be subject to UK immigration requirements as well as Civil Service nationality information on whether you are able to apply is availablehere.

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must completebasic personnel security standard checks.

Certain roles within the MHRA will require post holders to have vaccinations and in some circumstances routine health surveillance. These roles include:

• Laboratory-based roles working directly with known pathogens

• Maintenance roles particularly those required to work in laboratory settings

• Roles that involve visiting other establishments where vaccination is required

• Roles required to travel overseas where specific vaccination may be required.

Applicants who are successful at interview will be as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicants details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes including Tax-Free Childcare. Determine your eligibilityhere.

Individuals appointed on level transfer will retain their existing salary and are responsible for ensuring they fully understand the financial implications of any potential move and the impact (if any) on their terms. If an individual is in any doubt they should seek clarification before accepting a job offer.

Staff joining on promotion will receive up to a 10% increase of their current basic salary or the pay band minimum whichever is the greater.

The individual will not retain any allowances paid by the former department/Agency unless there are special circumstances such as a reserved right to those allowances on transfer.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact.

In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointmenton the basis ofmerit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint you should firstly contact

If you are not satisfied with the response you receive you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1Horse Guards Road

London

SW1A 2HQ