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THE ROYAL MARSDEN NHS FOUNDATION TRUST IN ASSOCIATION WITH THE INSTITUTE OF CANCER RESEARCH JOB DESCRIPTION CLINICAL FELLOW IN PAEDIATRIC ONCOLOGY DRUG DEVELOPMENT Full Time Post One year fixed-term contract THE ROYAL MARSDEN NHS FOUNDATION TRUST The Royal Marsden is recognised worldwide for the quality of its cancer services. The Royal Marsden NHS Foundation Trust’s strategic aim is to achieve excellence in cancer treatment and diagnosis, through partnership and collaboration. In association with The Institute of Cancer Research it constitutes a centre of excellence for research and development, education, treatment and care in cancer, and the combined institutions form one of the largest comprehensive Cancer Centres in the world. The prime purpose of the Trust is the provision of state of the art cancer services as well as enabling research into the development of improved methods of prevention, diagnosis and treatment of cancer. Its other main purpose is teaching and the dissemination of knowledge both nationally and internationally. In 1991 it became the first NHS hospital to be awarded the Queen’s Award for Technology for its work on drug development. The hospital achieved the international quality standard ISO 9001 for radiotherapy in 1996 and for chemotherapy in 2003. It was recognised as one of six centres of excellence in the Government’s NHS Plan and has achieved four national Charter Marks for all its services. The Royal Marsden has consistently been awarded three stars in the NHS performance indicators, rating it among the nation’s best in terms of clinical quality and patient care. As a leading Cancer Centre the Trust has close working relationships with many Cancer Units and other Cancer Centres. Predominantly the Trust’s workload is from within the South West and West London Cancer Networks but the Trust is unique in having a high out-of-area referral rate for rare cancers, recurrent disease and treatment-related problems. The Trust forms a joint cancer centre with St. George’s Healthcare NHS Trust. The Royal Marsden’s new 31-bed Oak Centre for Children and Young People is one of the largest comprehensive cancer centres in Europe for children and teenagers. The Centre Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 1 sees almost 600 inpatients and more than 5,000 day patients every year. It is based in the heart of the hospital which means our young patients benefit from a wealth of expertise, which ensures that the care provided is both comprehensive and tailored to their specific needs. The Royal Marsden NHS Foundation Trust comprises two units (169 beds at Chelsea, and 184 beds at Sutton). Over 40,000 patients attend the Royal Marsden each year. The Trust employs 2300 staff, including 300 medical staff. As a specialist cancer centre, the Trust serves local populations within the London Boroughs of Merton, Sutton, Wandsworth, Kensington & Chelsea and Westminster, as well as receiving referrals both nationally and internationally. The Royal Marsden supports a number of junior doctor training programmes, and provides core training across a wide range of tumours in Clinical and Medical Oncology and Surgical Oncology (including gynaecological cancer, gastro-intestinal, breast cancer and sarcoma and melanoma). The Trust also participates in rotations for the training of junior doctors in a number of other specialties. Organisation The Trust Board comprises an independent chair, Mr Ian Molson, executive directors, and five non-executive directors from outside the NHS. At The Royal Marsden NHS Foundation Trust the hospital management structure is organised into three Divisions; Cancer Services, Clinical Services and Community Services. Each Division is led by a Divisional Director, reporting to the Chief Operating Officer, and supported by a Divisional Medical Director. The lead consultant for each Clinical Unit or specialty is a member of the Medical Advisory Committee. This is chaired by the Medical Director, Dr Nick van As, who together with the other directors (i.e. Chief Nurse, Finance, IT, Strategy & Service Development, HR, Private Practice and Estates) and the Divisional Directors form the Clinical Executive Board. The Management Executive is chaired by the Chief Executive, Miss Cally Palmer. The Consultant leads of each clinical unit or specialty formally meet as the Divisional Management Team on a bi-monthly basis. Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 2 Clinical Services Division: Radiology, Pathology, Pharmacy, Theatres, Day Surgery, Palliative Care, Physics, Radiotherapy, Critical Care, Cancer Genetics, Medical Records & Patient Transport, Outpatients, Anaesthetics, Rehabilitation, Transitional Care Unit, Academic Biochemistry, SSD, Pain Services, Nuclear Medicine, Minor Procedure Suite, Endoscopy, Minor Procedures Suite, Central Referrals, Equipment Library. Cancer Services Division: Breast, Lung, GI, Neurology, Gynaecology, Urology, Day Care including IV team and Medical Day Unit, Breast Diagnostic Unit including Rapid Diagnostic & Treatment Centre (RDAC), Sarcoma, Head & Neck, Thyroid, Neuro-oncology, Leukaemia & Myeloma, Clinical Pharmacology, Lymphoma, Paediatrics, Drug Development Unit, Cell Bank, Academic Haematology. Community Services Division: The Royal Marsden is the provider of Sutton and Merton Community Services. These include health visitors, specialist community nurses, outpatient physiotherapy, podiatry, falls service and children’s physiotherapy in the Sutton and Merton area. The Divisions are supported by the following corporate directorates: Nursing, Rehabilitation and Quality Assurance Directorate: Rehabilitation, Pastoral Care, Lymphoedema, Volunteer Services, Community Liaison, Social Services, Quality Assurance, Research, Practice and Professional Development. Finance, Human Resources, Computing and Information, Estates and Private Practice THE INSTITUTE OF CANCER RESEARCH The Institute of Cancer Research is a College of the University of London. It was established in 1909 to investigate the causes of cancer and develop new strategies for its prevention, diagnosis, treatment and cure and is now a centre of excellence employing some of the world’s leading scientists working on cutting edge research. The Institute is located adjacent to both the Chelsea and Sutton sites of the Royal Marsden and is closely integrated with the clinical NHS provision. Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 3 Research The joint research interests of The Institute and the Trust are extensive and complementary, with an increasing emphasis on translational research. Research is carried out in a number of Divisions (Breast Cancer Research, Cancer Biology, Cancer Therapeutics, Clinical Studies, Genetics and Epidemiology, Molecular Pathology, Radiotherapy and Imaging, Structural Biology), Academic Departments, and Clinical Units, and the research in the joint institution can be grouped into 9 distinct themes: paediatric oncology, breast cancer, cancer diagnosis and imaging research, cancer genetics, cancer therapeutics, haematological cancers, healthcare research and screening, molecular pathology, radiotherapy and oncology. The majority of research funding comes from external sources and the grant success rate for The Institute is outstanding, at average 81% (by value) 2003-2007 of all applications from peer-reviewed grants to medical charities and government funding agencies. The Institute is particularly indebted to its major sponsoring partners – Cancer Research UK, Breakthrough Breast Cancer, Leukaemia Research, the Kay Kendall Leukaemia Fund, Prostate Cancer Charitable Trust, Association of International Cancer Research, Breast Cancer Campaign, and to many other medical research charities. In addition, commercial partners collaborating in drug development at The Institute and supporting clinical trials at The Royal Marsden include Vernalis, Astex, Novartis, Astra Zeneca, Roche-Genentech, Glaxo-Smith-Kline, amongst others. As a UK higher education institution, The Institute receives substantial public funding directly from the Higher Education Funding Council for England (HEFCE) each year. This money is awarded in direct recognition of The Institute’s scientific excellence, which is measured by the quinquennial Research Assessment Exercise (RAE). The Institute once again produced outstanding research ratings in the most recent RAE, with The Institute receiving the highest percentage of research assessed as four stars, world leading, in the areas of biological sciences and cancer studies. Training There are currently well over 100 MPhil/PhD Students (including clinical fellows and part-time students) as well as MD (Res) students. In addition there is a locally funded Clinical Research Fellowship Programme and over 100 MSc students registered on The Institute's MSc in Oncology. Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 4 CHILDREN’S AND YOUNG PEOPLE’S UNIT Consultant Paediatric Oncologists/ HaematologistsDr J Chisholm Consultant Paediatric Oncologist with an interest in Sarcoma and Young People, Clinical Head of Unit. Honorary Faculty ICR, Divisions of Clinical Studies and Molecular Pathology Dr D Lancaster Consultant Paediatric Oncologist with an interest in leukaemia / lymphoma and early phase trials for haematological malignancies and Deputy Research Lead (Phase III studies) and current Interim Research Lead Dr M Taj Consultant Paediatric Oncologist with an interest in leukaemia / lymphoma / late effects Dr S Vaidya Consultant Paediatric Oncologist with an interest in neuro-oncology and solid tumours based 50% at St George’s Hospital. Dr S Zacharoulis Consultant Paediatric Oncologist with an interest in neuro-oncology and solid tumours based 50% at St George’s Hospital. Dr L Marshall Oak Foundation Consultant Oncologist in Paediatric and Adolescent Drug Development with an interest in Neuro-oncology and Neuroblastoma; Deputy Research Lead (Phase I/II Studies) Dr L Moreno Honorary Consultant Paediatric Oncologist in Drug Development with an interest in Neuroblastoma Professor L Chesler Honorary Consultant, Team Leader in Paediatric Oncology – Neuroblastoma and Medulloblastoma Drug Development, Institute of Cancer Research Divisions of Clinical Studies, Cancer Therapeutics and Cancer Biology Dr A Atra Consultant Paediatric Haematologist with an interest in malignant, benign haematology and Langerhans Cell Histiocytosis. Based 50% at St George’s Hospital Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 5 DrElsje Van Rijswijk Locum Consultant Paediatric Oncologist with an interest in malignant haematology. Based 70% at St George’s Hospital In addition, the appointment of a new Paediatric Research Lead and Honorary Consultant in Paediatric Drug Development is pending mid-2016, following the retirement of the previous post-holder and a recent international recruitment process. Consultant Paediatric Palliative Care Dr AK Anderson Consultant Clinical Oncologists Dr F Saran Dr H Mandeville Consultant Haematologists with responsibility for Adult and Paediatric Bone Marrow Transplantation Dr M Potter Dr M Ethell Consultant Paediatric Endocrinologist Dr A Albanese Consultant Anaesthetist Dr R Self - Lead Consultant Anaesthetist Dr D Chisholm, Dr O Lacey, Dr A McLeod, Dr A Oliver, Dr R Juneja Consultant Radiologists Dr D MacVicar - Lead Paediatric Radiologist Dr OM Koh – Consultant in Functional Imaging with an interest in Paediatric oncological imaging Dr D Levine – Consultant in Functional Imaging with an interest in Paediatric oncology imaging Consultant Paediatric Surgeons Mr B Okoyo (Honorary Consultant) St George’s Hospital) Mr S Guiliani (Honorary Consultant) St George’s Hospital) Mr Z Mehta (Honorary Consultant) St George’s Hospital) Mr E Nicholls (Honorary Consultant) St George’s Hospital) Mr CK Sinha (Honorary Consultant) St George’s Hospital Consultant Paediatric Neurosurgeons Mr S Stapleton (Honorary Consultant, St George’s Hospital) Mr A Martin (Honorary Consultant, St George’s Hospital) Mr C Chandler (Consultant, Kings College Hospital) Consultant Histopathologists Professor C Fisher Dr A Wotherspoon Dr K. Thway Dr S O’Connor Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 6 Consultant Paediatric Histopathologists Dr I Jeffrey (Honorary Consultant) St George’s Hospital Dr R Nash (Honorary Consultant) St George’s Hospital Consultant Paediatric and adolescent Psychiatrist Dr J Khor Consultant Clinical Psychologists Dr L Edwards Consultants Paediatric Infectious Disease Prof M Sharland (Honorary Consultant) St George’s Hospital Dr P Heath (Honorary Consultant) St George’s Hospital Consultant Paediatric Neurologists Dr A Clarke ((Honorary Consultant) St George’s Hospital Dr P Fallon (Honorary Consultant) St George’s Hospital Nurse Consultant in for Adolescents and Young Adults Louise Soanes Matron for Children’s and Young People’s Services Carly Snowball Speciality Doctors Dr Jane Passmore Dr Martha Perisoglou Dr Rubina Malik (SGH) 1 additional post pending appointment Junior Medical Staff Specialist Training paediatric registrar Year 6-8 Specialist Training paediatric registrar Year 3 Clinical Service Fellow Bone marrow Transplant Fellow Paediatric Drug Development Fellow 3 FTE 2 FTE 3 FTE 1 FTE 3 FTE Children and Young People Outreach and Symptom Care Nurse Specialists (POONS) Team 3 x Clinical Nurse Specialists (leukaemia, solid tumours, neurooncology) 2 Specialist Sisters The Children’s and Young People’s Unit of the Royal Marsden NHS Foundation Trust, Sutton is based in an internationally renowned cancer centre; has excellent integration with all adult oncology specialities and enjoys the significant benefits of co-location with The Institute of Cancer Research. The on-site radiotherapy facilities have undergone extensive expansion. The clinical oncology service for children and young people with malignancy has a very high international reputation and has an established record in innovative radiotherapy techniques. It is one of the larger Children’s Cancer and Leukaemia Group (CCLG) centres. The Children’s and Young People’s Unit has an excellent, well established paediatric oncology nursing service and has a robust and well developed mechanism for shared-care. Patients Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 7 have rapid access to high quality diagnostic techniques. There is excellent multidisciplinary care with well developed, integrated psycho-social, educational and family support. The Royal Marsden Hospital NHS Foundation Trust opened a new Teenage Cancer Unit at the Sutton site, in January 2012. The Royal Marsden NHS Foundation Trust and St Georges Hospital form a unified, integrated paediatric oncology centre for children with malignancy south of the Thames. The Royal Marsden Hospital provides cancer diagnosis, cancer treatment expertise, psychosocial support and non-surgical cancer therapy and St George’s Hospital provides paediatric specialist services, including paediatric intensive care, paediatric surgery, neuro-surgery and paediatric infectious disease specialist care. Local, comprehensive, integrated, high quality care for children and young people with malignancy is delivered by robust clinically governed programmes and patient pathways. Treatment is according to current international therapeutic protocols and trials. The Unit’s philosophy of family-centred care has been developed by involving parents and carers with the treatment plan, both in the hospital and at home. Families have open access to the unit and a community liaison team facilitates home treatment and shared care with local hospitals. Early return to school is encouraged and the teachers and social workers based on the unit work closely with schools and other community based services. The Royal Marsden, in collaboration with the two regional paediatric neuro-surgical centres (St Georges & Kings College Hospital), has been developing a comprehensive South Thames Paediatric Neuro-oncology Service and is one of the largest paediatric neurooncology units in the UK. There is close joint working between the paediatric and adult neuro-oncology teams in the form of weekly joint multi-disciplinary team (MDT) meetings and joint clinics. There is a well-established allogeneic Haematopoetic Stem transplant programme with two joint Adult and Paediatric Stem Cell Transplant consultants. This is complemented by an active programme for myeloablative procedures requiring autologous haemopoeitic stem cell rescue. There is on-site provision of total body irradiation. There is a very active, innovative, Palliative Care and Symptom Control Service led by a dedicated Consultant in Paediatric Palliative Care, providing twenty four hours out of hours care and linking with a local Hospice. Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 8 The Children’s and Young People’s Unit clinical facilities at the Royal Marsden Hospital Sutton are in a purpose built substantial new £20 million build which was opened in September 2011. It comprises 18 children inpatient beds, outpatient and day care facilities, a dedicated 13 bed Teenage and Young Adult Cancer Unit, including beds for children’s and young people’s drug development. The Unit has approximately 220 new malignant registrations per year, including children with leukaemia, central nervous system and extra cranial tumours. Children are referred from south of the Thames, Kent and the south coast, although for early phase studies patients are referred from all around the UK via defined referral networks, with a third of patients recruited to paediatric early phase studies coming from out of region. The Unit is currently involved in multi-centre national and international trials evaluating new therapeutic strategies. The research activities of the clinical Unit are closely integrated with the Division of Cancer Therapeutics, The Institute of Cancer Research. The overall goal of the research strategy is to improve the five year survival of childhood and adolescent cancer via the Paediatric and Adolescent Oncology Targeted Drug Development Programme at The Institute of Cancer Research / Royal Marsden NHS Foundation Trust. This comprehensive programme comprises drug discovery, pre-clinical evaluation, early clinical trials and a clinical facility (the Oak Foundation Unit). The clinical facility includes four Phase I inpatient beds (with potential to increase this number further on the Teenage and Young Adult Unit), outpatient chairs and daycare beds together with an adjacent laboratory on site for pharmacokinetic and pharmacodynamic sample processing, and two new suites for radioisotope therapy which will help facilitate novel studies involving radioisotope components. Over the past seven years, funding from the Oak Foundation has facilitated the development of a strong Paediatric and Adolescent Drug Development Team of twenty three dedicated individuals with expertise and knowledge in the field of drug development. Oak Foundation funding has provided pivotal staff (including the Oak Foundation Consultant in Paediatric and Adolescent Oncology Drug Development post, part funding for a Honorary Consultant, two part-time research nurses, one part time clinical trial co-ordinator, an academic personal assistant to the Drug Development Team and a clinical fellow in radiology to work specifically in the area of paediatric early phase trials and functional imaging). Additional staff are funded via other sources (two dedicated senior Drug Development Fellows with a third due to be Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 9 appointed shortly, additional research nurses, trial co-ordinators, data managers, and a tissue collector). Several of the existing NHS consultants work closely with the team taking responsibility for organisation and recruitment for some of the tumour-specific early phase trials, including phase I & II trials. This clinical Paediatric and Adolescent Drug Development Team has developed a broad and increasing portfolio of molecularly targeted agents and plays a key role within European Paediatric Drug Development networks as well as being increasingly involved in the design and conduct of transatlantic paediatric cancer early phase studies. The team integrates closely with translational scientists and clinicians with extensive research and trial experience. The Unit has already been able to capitalise on these developments and is now poised to do so even further. This supporting infrastructure has allowed the paediatric early phase clinical trials portfolio to increase from just 2 open studies in 2006 to 26 open studies in 2015 (18 of these molecularly targeted agents; 15 first in child studies), with further new studies opened/opening in 2016. This is the largest portfolio of paediatric early phase trials in the UK and one of the largest in Europe. A third of children treated in phase I/II clinical trials were referrals from outside our catchment area. We are increasingly able to: Select novel agents based on: New pre-clinical models, which we believe will be more predictive of clinical activity; Tumour molecular biology; Base clinical trials on strong biological hypotheses, including pharmacodynamic biomarkers to show proof-of-target inhibition and downstream effects; Develop clinical trial designs that do not require large numbers of patients; Increase the availability of new agents for paediatric investigation by strong links with pharma Play a leading role in recruiting into international collaborative early clinical studies. THE POST The position will be a key post in the Paediatric and Adolescent Oncology Targeted Drug Development Programme. The Paediatric and Young People's Targeted Drug Development Programme at the Royal Marsden Hospital / The Institute of Cancer Research encompasses molecular pathology, Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 10 drug discovery, preclinical investigation (in a comprehensive range of model systems), preclinical imaging and early clinical studies with functional imaging and pharmacodynamic biomarker analysis. The Fellow will work very closely with other members of the multidisciplinary team carrying out early clinical studies of novel agents in children and young people at the Royal Marsden Hospital. The established team comprises Paediatric Drug Development Consultants Research Nurses, Clinical Fellows, Clinical Trial Co-ordinators, Data Managers and Tissue Collectors. The Fellow will be involved in the care of children and young people enrolled on early clinical studies of new agents. The team has strengthened the high quality standards of Good Clinical Practice (GCP) and developed excellent links with academic and industrial sponsors. Patients are referred from other centres and there has been very positive feedback from referring clinicians, their shared care colleagues and the families themselves about the service for these patients. The team works to an excellent patient care level with strong pharmacovigilance. There have been three external audits in the past four years and no critical or major findings were found. The Team were praised on their dedication to meet GCP standards. In addition there will be opportunities to be involved in devising and writing early clinical studies, develop paediatric biomarker platforms and input into pilot imaging studies. The Fellow will also have an opportunity to develop an interest in neuroblastoma, neurooncology, sarcoma or leukaemia. The post holder would be responsible for reviewing patients on Phase I/II clinical trials, both on the ward and in the Paediatric Drug Development clinics. The post holder will receive training in and be actively involved in liaising with academic and commercial clinical trial sponsors about patients recruited onto trials, new trials and new drugs, collection of clinical trial data to GCP standards and the regulatory aspects of paediatric early phase trials to enable them to work effectively in the set-up of new early phase trials, under consultant supervision. There are particularly strong links with the Cancer Research UK Cancer Therapeutics Unit, the Adult Drug Development Unit – Oak Ward and the Department of Nuclear Medicine (RMH) and the Cancer Research UK and EPSRC Cancer Imaging Centre. The post holder will link closely with radiology colleagues for the imaging assessments of patients on clinical trials. Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 11 A central theme of the programme will be the translation of laboratory research to clinical trials, which will ultimately alter international practice in paediatric oncology. This post in paediatric oncology is suitable for trainees wishing to gain experience in paediatric oncology drug development. The post holder will have the opportunity to develop their own projects in the area of drug development. Ideally the post holder will have already obtained a higher degree, be in the process of doing so or have a strong interest in pursuing such an opportunity in the near future. The post holder will take part in the paediatric oncology on call rota at SpR level. Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 12 PERSON SPECIFICATION CLINICAL FELLOW IN PAEDIATRIC ONCOLOGY DRUG DEVELOPMENT Person Qualities and Attributes Essential Desirable Specification Status Membership of the Royal College of and Paediatricians Child Health or equivalent qualifications. Eligible for full GMC Registration. Advanced Paediatric Life Support or equivalent certificate. A Higher Degree or desire to pursue one at a later stage. Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 13 Experience Broad-based experience in Paediatrics and Paediatric Oncology Organisation of education and training of junior doctors. Experience in medical audit IT skills Training and/or Experience in regulatory relevant to matters paediatric clinical research Personal Approachability Team Player Enthusiasm Effective communication Qualities Committed to personal and professional development Job Description Clinical Fellow in Paediatric Oncology Drug Development 22-04-2016 14