Medicines and Healthcare Products Regulatory Agency

Deputy Head of Clinical Investigations

Information:

This job is now closed

Job summary

We are seeking aproactive, confidentand enthusiasticDeputy Head of Clinical Investigationsto join ourInnovation AcceleratorfunctioninScientific Research & Innovationgroup. This is afull-timeopportunityon afixed-term/loan/secondment basis until 31stMarch 2025.

The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU and/or our South Mimms, Hertfordshire site. Please be aware that this role can only be worked in the UK and not overseas. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 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 8 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

TO BE CONSIDERED FOR THIS ROLE, PLEASE APPLY ON MHRA WEBSITE (http://lhrc1a.rfer.us/MHRAh.l1Fm). ONLY APPLICATIONS RECEIVED ON MHRA WEBSITE WILL BE CONSIDERED

Main duties of the job

The key purpose of this role is to work in collaboration with the Head of the Integrated Devices Access Pathway and Head of Clinical Investigations to ensure the efficient, pragmatic, proportionate and patient-centred performance of the clinical and non-clinical assessment of clinical investigations into the performance and safety of medical devices and diagnostics.

The role offers an exciting opportunity to be at the forefront of medical device innovation to address unmet patient needs.The post holder will also participate in the deployment of the Innovative Devices Access Pathway (IDAP). The aim of the pathway is to improve patient access to innovative technologies by providing developers with joined up support and advice from across the UK.

About us

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 Science, Research, and Innovation Group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.

The Innovation Accelerator (IA) provides innovators access to the Agencys scientific expertise and regulatory guidance, helping developers of innovative products (medicines, medical devices (including software) and blood components for transfusion) connect more dynamically with an enhanced advice and signposting service.

Details

Date posted

24 July 2023

Pay scheme

Other

Salary

£67,158 a year + benefits

Contract

Fixed term

Duration

18 months

Working pattern

Full-time

Reference number

K0015-REG002

Job locations

10 South Colonnade

Canary Wharf

London

E14 4PU


N I B S C

Blanche Lane

South Mimms

Potters Bar

Hertfordshire

EN6 3QG


Job description

Job responsibilities

Key responsibilities:

The post holder will have a significant role in developing and delivering the innovative devices access pathway (IDAP). This will include delivering supportthrough the clinical investigations tool offered to devices awarded an innovation passport.

Manage the functions of the Clinical Investigations team in liaison with the Head of Clinical Investigations, to achieve an income, expenditure and headcount as agreed in the annual budget.

Support and deputise for the Head of Clinical Investigations to ensure the quality and consistency of assessment decisions made to protect public health, identifying synergies, and streamlining opportunities to enhance the UK research environment

Be responsible for ensuring the clinical investigation review process meets statutory deadlines, ensuring appropriate technical and clinical input is sought.

Job description

Job responsibilities

Key responsibilities:

The post holder will have a significant role in developing and delivering the innovative devices access pathway (IDAP). This will include delivering supportthrough the clinical investigations tool offered to devices awarded an innovation passport.

Manage the functions of the Clinical Investigations team in liaison with the Head of Clinical Investigations, to achieve an income, expenditure and headcount as agreed in the annual budget.

Support and deputise for the Head of Clinical Investigations to ensure the quality and consistency of assessment decisions made to protect public health, identifying synergies, and streamlining opportunities to enhance the UK research environment

Be responsible for ensuring the clinical investigation review process meets statutory deadlines, ensuring appropriate technical and clinical input is sought.

Person Specification

Experience

Essential

  • Our successful candidate will have significant, relevant experience in regulation of clinical investigations of medical devices as well as minimum degree in a Science or clinically relevant qualification with previous experience relevant to Clinical Investigations and Trials. You will have excellent organizational, IT and excellent written and oral communication skills, able to provide concise briefings to colleagues and stakeholders, and influence outcomes in a range of situations. You will have good project management skills and ability to work within a team and across other functions to contribute and manage projects effectively. You will also be a strong team player with ability to forge working relationships across different functions.
Person Specification

Experience

Essential

  • Our successful candidate will have significant, relevant experience in regulation of clinical investigations of medical devices as well as minimum degree in a Science or clinically relevant qualification with previous experience relevant to Clinical Investigations and Trials. You will have excellent organizational, IT and excellent written and oral communication skills, able to provide concise briefings to colleagues and stakeholders, and influence outcomes in a range of situations. You will have good project management skills and ability to work within a team and across other functions to contribute and manage projects effectively. You will also be a strong team player with ability to forge working relationships across different functions.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

10 South Colonnade

Canary Wharf

London

E14 4PU


Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

10 South Colonnade

Canary Wharf

London

E14 4PU


Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)

Employer contact details

For questions about the job, contact:

Recruitment Team

Careers@mhra.gov.uk

Details

Date posted

24 July 2023

Pay scheme

Other

Salary

£67,158 a year + benefits

Contract

Fixed term

Duration

18 months

Working pattern

Full-time

Reference number

K0015-REG002

Job locations

10 South Colonnade

Canary Wharf

London

E14 4PU


N I B S C

Blanche Lane

South Mimms

Potters Bar

Hertfordshire

EN6 3QG


Supporting documents

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