clinical specialist Salisbury, England
Job description
Details
Reference number
Salary
Job grade
Contract type
Business area
Type of role
Working pattern
Number of jobs available
Contents
Location
About the job
Benefits
Things you need to know
Apply and further information
Location
About the job
Job summary
The work of the Toxicology, Trauma and Medicine Group within the Chemical, Biological and Radiological (CBR) Division aims to prevent or mitigate the lethal and incapacitating effects of chemicals and physical (traumatic) injury. This is achieved by exploring pre- and/or post-exposure pharmaceutical therapies as well as novel concepts for passive protective measures. The work covers early stage innovative research through to clinical development and drug licensure. The research and development outcomes inform a range of strategic and policy decisions across MOD and wider government.
We are seeking a non-clinical study monitor to join the Advanced Development Programme (ADP) team. The successful candidate will join a small and highly skilled, multi-disciplinary team working closely with medical and scientific research colleagues. The primary focus for the successful candidate will be non-clinical scientific co-ordination of product safety studies to support novel pharmaceutical regulatory submission. This will include desk-based research of existing literature and data from innovative efficacy studies, as well as overseeing packages of non-clinical safety studies that are placed at external Contract Research Organisations (CROs).
Dstl recognises the importance of diversity and inclusion as people from diverse backgrounds bring fresh ideas. We are committed to building an inclusive working environment in which each employee fulfils their potential and maximises their contribution.
Job description
In this role you will:
- Work collaboratively across inter-disciplinary teams across the non-clinical/clinical interface to ensure robust studies are planned, carried out to the required non-clinical and regulatory standards and reported appropriately.
- Have responsibility for coordinating the activities for non-clinical toxicology studies for regulatory submission, in compliance with the appropriate standards.
- Provide scientific and administrative support to the project team for assigned studies from award, through the in-life phase and reporting.
- Proactively liaise with external contractors and internal project teams to ensure accurate and timely conduct of the agreed studies.
- Manage and conduct interactions with external partners to ensure positive and trusted relationships are developed.
- Provide proactive support to suggest and implement action plans for solving study problems should they occur
- Apply regulatory requirements and guidance effectively to define non-clinical project strategies.
- Contribute to regulatory documentation and submissions to MHRA.
- Provide robust and reliable toxicology advice to MOD stakeholders to enable informed decision making.
- Write literature reviews pulling together data from a variety of studies to inform project outcomes.
Person specification
We are looking for someone with the following;
- Degree in Biomedical, Biochemical, Biological or Pharmaceutical Sciences (or equivalent)
Desirable Qualifications
- Post-graduate certifications in toxicology, regulatory affairs or product safety
Essential Experience
- Previous or current experience as a GLP Study monitor/Study director
- Non-clinical study experience in pharmaceutical development.
- Demonstrable experience of writing and reviewing study protocols and reports
- An effective team player
- Good IT Skills - proficient in MS Office Word, Excel, PowerPoint and Outlook.
- Experience of toxicology and/or pharmacology in pharmaceutical development
- Experience of managing internal and subcontracted non-clinical studies.
- Experience in a client facing role
- Excellent communication and time management skills
- Excellent attention to detail and consistent accuracy whilst managing multiple changing priorities
- Knowledge of regulatory agency guidelines and Home Office requirements
- Experience of ADME/DMPK principles
Important Information
Our work in defence, security and intelligence requires our employees to be UK Nationals who are able to gain a high level of security clearance to undertake the projects we are involved in to protect us from security threats. For this reason, only UK Nationals will be able to apply for this role. If you are an international or dual-national candidate, and you think you have the skills we need, please consider applying to any of our government, security or defence partners.
This role will require full UK security clearance and you should have resided in the UK for the past 5 years. For some roles Developed Vetting will also be required, in this case you should have resided in the UK for the past 10 years.
Behaviours
We'll assess you against these behaviours during the selection process:
- Communicating and Influencing
- Delivering at Pace
- Working Together
- Developing Self and Others
Technical skills
We'll assess you against these technical skills during the selection process:
- Please tell us how you would approach study design
Benefits
Benefits
Dstl’s full range of great benefits can be found in the information pack which includes:
Financial: An excellent pension scheme starting from 26% employer contribution (find out more here). In Year Rewarding Achievement bonuses and thank you vouchers. Rental deposit scheme and cycle to work scheme.
Flexible working: Options include alternative working patterns such as; compressed hours (e.g. working a 4 day week/ 9 day fortnight), job shares and annualised hours (agreed number of hours per annum paid monthly i.e. working term-time only).
Working hours: Flexibility around your working day (e.g. start time, finish time). Ability to bank hours in a 12 month reference period including the ability to accrue and use 3 days per calendar month.
Where you work: Depending on your role, blended working may be available including remote working to suit you and your team. This can be discussed at interview.
Annual leave: 25 days pro rata (rising to 30 after 5 years) plus 8 public holidays with the ability to buy/sell 5 additional days per annum.
Family: Maternity, adoption or shared parental leave of up to 26 weeks with full pay, an additional 13 weeks statutory pay and a further 13 weeks unpaid
Learning and Development: Dstl encourages and supports charterships, accreditations and provides employees access to fully funded apprenticeships up to level 7 (Masters Degree). Dstl will pay for 2 memberships with relevant bodies/institutions. Employees also have access to Civil Service Learning.
Facilities: Onsite parking, EV Charging points, restaurants, cafés and gyms.
Things you need to know
Selection process details
The sift will be completed the week after the closing date and will assess your answers to the Technical skills questions and how your CV/Personal Statement matches the requirements for the role as detailed in the attached job description.
The Interview will consist of a combined technical and behavioural interview assessing your skills and experience in relation to the job description.
We want you to have your best chance of success in our recruitment process, so If at any stage of the application process you would like help or assistance please contact the Dstl Recruitment Team [email protected] and we will do all we can to support you
Feedback will only be provided if you attend an interview or assessment.
Security
See our vetting charter (opens in a new window).
Nationality requirements
This job is not open to candidates who hold a dual nationality.
Working for the Civil Service
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).
Apply and further information
Contact point for applicants
Further information
