UNIVERSITY OF SOUTHAMPTON
Faculty of Medicine
Director of the Clinical Trials Unit
Particulars of Appointment
The Faculty of Medicine is seeking a Director for its Clinical Trials Unit. This unit was
initially established with core funding from Cancer Research UK, which was successfully
renewed in 2013, but it has the aim of hosting trials across the whole range of health care,
with additional core support from NIHR. The Unit provides the infrastructure for the
planning, design, conduct and analysis of therapeutic and other clinical trials, spanning from
first in man to large randomised studies.
The Unit provides key personnel in statistics, data management, research governance and
information systems, with further funding on a project-specific basis as studies are
developed.
The successful applicant will need to have a successful background in clinical research,
either as a clinical trialist or in the field of trial design and analysis.
The Director will be responsible for continuing to build an internationally recognised Trials
Unit with a substantial portfolio of studies funded through competitive grants. In order to do
this they will be expected to develop and manage a multidisciplinary team covering the
different areas of expertise necessary for such a Unit.
It is expected that the person appointed (clinical or non-clinical) will contribute to the
academic leadership within the Faculty to enhance the quality of the Faculty’s research in
Hospital-based clinical subjects.
Information for all applicants
The University of Southampton is a leading research-intensive University, a member of
the Russell Group and one of the top 100 universities worldwide. We deliver an excellent
educational experience, world-leading research and we are known for successfully
commercialising that research through enterprise.
This is an exciting time to join the University of Southampton. We have an aspirational
University Strategy (see www.southampton.ac.uk/strategy), setting out our ambitions over
the next five years. The strategy involves achieving a top 10 place in the UK for research,
which we will achieve by investing in the highest quality staff and facilities. We are also
transforming the education offer available to undergraduate and postgraduate students
across the University, providing greater flexibility and modular courses, with a strong
international focus.
The Faculty of Medicine has strong foundations of basic research and clinical translation.
Working with colleagues across the University and in the local NHS we have strengthened
our position as a renowned centre for clinical and translational research, leading innovative
learning and discovery for better health across the lifecourse. The Clinical Trials Unit is an
example of this, having developed a portfolio of studies spanning from experimental
medicine to international randomised trials. We are looking to appoint an outstanding
individual to continue this process, with a strong record in clinical research, either as a
clinician or a statistician.
Key to the success of the Faculty of Medicine is the delivery of high-quality education for
undergraduate and postgraduate students, building on our partnership in biomedical
research with Southampton University Hospitals NHS Trust and fostering new collaborations
with the physical sciences, including chemistry, engineering and computing. The Director of
the Clinical Trials Unit will play a key role in these developments.
The Faculty of Medicine has a clear research strategy to investigate the biomedical basis of
common human diseases and to translate this into clinical practice. The Faculty’s research
is delivered through four Academic Units:
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Cancer Sciences
Human Development and Health
Clinical and Experimental Sciences
Primary Care and Population Sciences
All research is organised and managed by these Academic Units, each of which has clear
evidence of international excellence.
Each carries a significant degree of devolved
responsibility for its research budgets and grants, space, equipment and personnel. The
Clinical Trials Unit is managed as part of the Cancer Sciences Academic Unit, although its
portfolio contains a number of trials in other areas of healthcare.
Working in close partnership with University Hospital Southampton NHS Foundation Trust,
translational research is delivered through the Southampton Centre for Biomedical
Research, bringing together the Cancer Research UK/NIHR Experimental Cancer Medicine
Centre, the Wellcome Trust Clinical Research Facility, the Southampton Clinical Trials Unit,
the Wessex Investigational Sciences Hub, the NIHR Biomedical Research Centre for
Nutrition and Lifestyle and the NIHR Biomedical Research Unit for respiratory medicine.
The Cancer Sciences Academic Unit consists of over 200 scientists, clinicians and
associated staff with a research budget in excess of £7m. Core funding to the Unit comes
from programme grants from Cancer Research UK and the Leukaemia Research Fund, with
major infrastructure support from the NIHR via the Experimental Cancer Medicine Centre
and the Clinical Trials Unit. The mission of the Unit has always focused on bringing together
the excellent clinical and basic research within the Faculty of Medicine and delivering high
quality translational research for improving cancer treatment.
The University of Southampton Clinical Trials Unit (UoSCTU) was formed in September
2006 with core funding from Cancer Research UK. Renewed core funding with an increased
level of funding was granted following a quinquennial review of the trials unit previous and
future activities submitted by Professor Eccles in 2012. The grant worth £2.3m supports key
members of the senior team as well as some core administrative posts. The current funding
period is from October 2013 to September 2018. Our cancer focus is currently around
haemato-oncology, gastrointestinal, urological cancers with a particular interest in early
phase studies in immunotherapy which complements the activities of the ECMC. The Unit
also benefits from NIHR CTU support funding (annual funding calculated based on NIHR
grant funding income) provides pump prime funding to establish stable capacity to increase
high quality submissions through NETSCC funding streams. The Unit is gradually expanding
activity in this area with large multicentre non-cancer IMP studies and a focus for non-IMP
surgical studies.
The Southampton Statistical Sciences Research Institute, known as S3RI, was set up
by the University in August 2003 to support and co-ordinate the research activities of
statisticians and demographers from the Schools of Social Science, Mathematics and
Medicine. It involves more than 50 academic, research and support staff and makes up one
of the largest groups of statisticians in UK universities. More than 35 research students are
currently supervised by one or more members of S3RI. The mission of the Institute is to
develop statistical research, including core statistical methodology and research motivated
by applied problems, to disseminate developments to a wide range of users of statistics
inthe sciences and government and to raise the national and international profile of
statistical research at Southampton through co-ordination and support of research activities.
The Southampton Centre for Biomedical Research (SCBR) lies at the core of the clinical
and biomedical research partnership between the University Hospital Southampton NHS
Foundation Trust and the University of Southampton. This body coordinates the people and
resources of our major clinical research facilities, units and centres which are supported by
£27m of National Institute for Health Research (NIHR) funded infrastructure. The Clinical
Trials Unit sits within this overall structure, giving the Unit ready access to the expertise
present in the statistics, epidemiology, public health and health economics groups. The
Director of the UoSCTU is a member of the Operational and Management Group of the
SCBR.
The UoSCTU have recently enhanced a close working relationship with the South Central
Research Design Service (RDS), the RDS (Director, Mark Mullee) provides expertise in
statistical trial design, health economics and grant submission focusing on investigators
developing proposals to submit to NIHR funding programmes. A jointly funded Senior
Statistician post works between the CTU and RDS to develop new proposals where CTU
support at some level is likely to be required.
Teaching in the Faculty of Medicine.
The Faculty of Medicine now has three pathways a medical degree, including the six year
widening access’ programme where students enter a ‘year 0’ foundation year.
The BM5 programme has a number of distinctive features. These include the integrated
nature of the teaching courses during which the scientific disciplines are taught together in a
clinical context using a systems-based approach, and the study-in-depth where students
undertake an eight-month supervised research project. The BM4 programme also has a
number of key features, including clinical topics in the first two years where they meet on a
regular basis in Graduate Groups with or without a facilitator; learning is with BM5 students
in the 3rd and 4th Years on all clinical attachments. All students take the same examinations.
Both programmes provide substantial clinical experience in the first two years, student
selected components, dispersed final year attachments and work shadowing prior to
commencing as a PRHO, and inter-professional learning. The “New Generation Project”
has developed a common learning programme of eight weeks which forms part of both BM,
and also ten other health professional programmes.
The Division of Medical Education consists of the Education Development Unit and the
Centre for Learning Anatomical Sciences. The Education Development Unit has strong
links with all other divisions to enable the promotion of high standards in teaching. The
School regards the quality of its educational provision as one of its major strengths and so
attaches great importance to the educational staff development programmes.
The Southampton medical curriculum contains a number of innovative features, such as the
blurring of the traditional distinction between the pre-clinical and clinical phases; placing a
basic science examination at the end of the third year in order to encourage the
reinforcement of systems course teaching during clinical attachments; study-in-depth and a
regional final year. A recent review of Years 1 and 2 has resulted in an increased
commitment to systems-based teaching.
The Faculty regards the development of teaching skills as being of great importance and
appropriate seminars and workshops are arranged by the Senior Lecturer in Medical
Education, as part of the Faculty’s academic staff development programme.
Information for clinical applicants
For clinically qualified applicant an honorary consultant contract with University Hospital
Southampton will be arranged and the post holder will be involved in clinical service delivery
in their specialist area. UHS expects all medical and dental staff to work within the
guidelines of the “General Medical Council Guide - Good Medical Practice”.
Subject to the provisions of the Terms and Conditions of Service, the post-holder will be
expected to observe the Trust's agreed policies and procedures, drawn up in consultation
with the profession on clinical matters.
In particular, where the post-holder manages employees of the Trust, he/she will be
expected to follow the local and national employment and personnel policies and
procedures. The post-holder will be expected to make sure that there are adequate
arrangements for hospital staff involved in the care of his/her patients to be able to contact
him/her when necessary.
All medical and dental staff employed by the Trust are expected to comply with its Health
and Safety Policy and procedures.
The post-holder will be responsible for the training and supervision of junior medical staff
that work with him/her and if so will devote time to this activity. If appropriate, the postholder will be named in the contracts of doctors in training grades as the person responsible
for overseeing their training and as the initial source of advice to such doctors on their
careers.
Terms and Conditions of Appointment
General Terms
a)
The dates of the appointment will be agreed with the successful applicant, but it is
hoped to fill the post as soon as possible.
b)
The appointee will be required to observe the Charter, Statutes and Ordinances of
the University and to carry out all orders and regulations of the Council. It should be noted
that these regulations include a policy of no smoking at work which, with the exception of
certain designated areas, prohibits smoking in most University buildings.
c)
The appointment will be made on a full-time or part-time basis and no other paid
work may be undertaken without the permission of Head of School. Permission is not
required for the occasional giving of lectures elsewhere and the publication of books and
articles. The appointees may, during their tenure of office, accept appointments as
examiners of candidates for degrees and diplomas at other institutions.
(d)
The appointment will be made on the basis of a permanent contract.
General Duties and Hours of Work
(a)
The hours of work will be such as are necessary for the performance of the duties of
the post.
(b)
The appointee is expected as an integral part of their duties, to engage in research
and to further the prosecution of research in the University.
(c)
The appointee is also expected to participate in the teaching work and administration
of the Department. This will include teaching and examining as required by the Regulations
from time to time approved by the Senate and to do all in their power to promote the
advancement of the study of their subjects and the welfare and corporate life of the
University.
As a member of the University the appointee may be required to serve on the Senate and
the appropriate Faculty Boards according to the Statutes and Ordinances from time to time
in force.
Miscellaneous Terms and Conditions
(a)
The appointee will be expected to observe the letter and spirit of the University's
Equal Opportunities Policy:
The University of Southampton confirms its commitment to a comprehensive policy of equal
opportunities in employment and for students in which individuals are selected and treated
on the basis of their relevant merits and abilities and are given equal opportunities within the
University. The aim of the policy is to ensure that no job applicant or employee, prospective
student or students, should receive less favourable treatment on any grounds which are not
relevant to good employment practice for staff or to academic ability and attainment for
students. The University is committed to a programme of action to make the policy fully
effective. The person appointed will be expected to work within the spirit and letter of the
University's Equal Opportunities Policy.
Holiday
Full-time members of the academic staff are entitled to an annual holiday on full pay. The
length of such holiday, which must normally be taken during University vacations, is in
conformity with departmental custom and practice.
Sick Leave
The sick leave regulations applicable to the post will be those relating to members of the
Academic and Related staff. A copy of these regulations will be sent to the successful
candidate.
Salary
The salary attached to the post will be on the University Senior Lecturer/Professorial (clinical
or non-clinical) pay scale. Salary payments are made in arrears in monthly instalments on
the last working day of each calendar month by credit transfer direct to a bank account.
Superannuation
The person appointed will be eligible to join (or continue in membership of) the Universities
Superannuation Scheme under which the member currently contributes 6.35% of salary.
Under the provisions of the Social Security Act 1986 membership of the University's scheme
cannot be compulsory and the person appointed will have the alternative options of joining
(or continuing in membership of) the State Earnings Related pension Scheme (SERPS), or
taking out a Personal Pension Scheme. A member of the Federated Superannuation
Scheme for Universities on 1 April 1975 may remain in that Scheme.
Subject to certain caveats, an Inland Revenue regulation was introduced in 1989 which
effectively means that the salary upon which an employer can base pension contributions is
limited. The sum increases annually for inflation and is currently £108,600.00. Thus, in
general, earnings above this level do not count for pension. There are some exceptions
within the rules, and in particular, they do not apply to those who were already in the
scheme before 1989.
Further information on pension arrangements will be sent to the successful applicants.
Removal Expenses
It is necessary that the person appointed shall live in or near Southampton. The University
will be prepared to make a contribution towards (a) the costs of removing the household and
personal effects of a person appointed from within the United Kingdom and (b) the legal
costs incurred for the purchase of a house in or near Southampton. Details of the scheme
will be made available to those candidates called for interview.
Applications
Please apply online;
Informal enquiries are welcome and should be addressed to Professor Diana Eccles
(d.m.eccles@soton.ac.uk) or Professor Peter Johnson, P.M.W.Johnson@soton.ac.uk
Interviews are likely to be held during late February 2014