Job Title: DEPUTY MEDICAL DIRECTOR / EXPEREINCED PHASE 1 PHYSICIAN
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Vacancy details
Vacancy description:
Job Code:
KP-2253
Job Title:
DEPUTY MEDICAL DIRECTOR / EXPEREINCED PHASE 1 PHYSICIAN
Job Category:
Physicians
Contract:
Permanent
Discipline:
Medical Director, Clinical Research Physician, Medical Advisor
Country:
United Kingdom
Location:
Avon, Bedfordshire, Berkshire, Buckinghamshire, Cambridgeshire, Cheshire, Cleveland, Cornwall, Cumbria, Derbyshire, Devon, Dorset, Durham, East Sussex, Essex, Gloucestershire, Hampshire, Herefordshire, Hertfordshire, Humberside, Isle Of Wight, Kent, Lancashire, Leicestershire, Lincolnshire, London - Central, Manchester, Merseyside, Norfolk, Northamptonshire, Northumberland, North Yorkshire, Nottinghamshire, Oxfordshire, Rutland, Shropshire, Somerset, South Yorkshire, Staffordshire, Suffolk, Surrey, Tyne And Wear, Warwickshire, West Midlands, West Sussex, West Yorkshire, Wiltshire, Worcestershire, Aberdeenshire, Angus, Argyll, Ayrshire, Banffshire, Berwickshire, Arran And Bute, Caithness, Clackmannanshire, Dumfriesshire, Dunbartonshire, East Lothian, Fife, Forfarshire, Inverness-Shire, Kincardineshire, Kinross-Shire, Kirkcudbrightshire, Lanarkshire, Midlothian, Moray, Nairnshire, Orkney, Peeblesshire, Perthshire, Renfrewshire, Ross & Cro
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
30 May 2008
SALARY + BENEFITS
Competitive Salary + Pension + Flexible Benefits Package + financial support for HMT activities + MDU and GMC as well as other relevant professional subscriptions.
BACKGROUND
Chiltern is Europe’s largest privately owned Clinical Research Organisation, with over 1300 employees and 21 offices throughout Europe, both Eastern and Western, North America and in Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones.
Chiltern Early Phase is a 42 bed Phase 1 Unit located within Ninewells Hospital and Medical School in Dundee. The unit has special expertise in “first in man” studies and is a world leader in systemic drug phototoxicity studies in humans.
We are looking for an experienced Clinical Research Physician who is looking to further their Clinical Pharmacology career and move into a senior role with a high degree of responsibility.
PRIMARY DUTIES
Medical Affairs
1. Act as Chief Investigator or Co-investigator for clinical studies.
2. As Chief Investigator, to be responsible for the safe and timely conduct of clinical trials in accordance with The Medicines for Human Use (Clinical Trials) Regulations 2004 and related GCP guidelines.
3. As Chief Investigator or Sub-Investigator be overall responsible for -
- Review of safety results.
- Determination of eligibility to participate in a clinical trial.
- Adverse event coding and reporting.
- Statutory notifications.
- Final signature of CRFs.
- Preparation and interpretation of safety, pharmacokinetic and pharmacodynamic data.
- Review and answering of medical data queries.
4. As Co-Investigator/Sub-Investigator, to assist the Chief Investigator, as delegated on a project specific basis and to act as Chief Investigator in absentia.
5. Line management responsibilities for Clinical Research Physicians, clinical assistants and any locum members of medical staff.
6. On a for cause basis only, involved in the day to day medical aspects of clinical studies, including -
- Medical screening of study subjects.
- On study physical examinations.
- Dosing, sampling and cannulation.
7. Liaise with sponsor regarding specific protocol / study requirements.
8. Assist sponsors in protocol/programme design.
Managerial/Training/Educational
1. Promote commercial activities to potential customers.
2. Involved in the development of commercial strategy in conjunction with other members of the Senior Management and the Business Development department.
3. Participate in the planning and organisation of company training days.
4. Participate in the planning and organisation of sponsor audits.
5. Attend in-house training days, and external study days where appropriate.
6. Ensure appropriate medical representation at the SOP committee and any other relevant committee.
Core Quality responsibilities include
1. To assist the Medical Director in the preparation of procedures and unit policy.
2. To provide an efficient and effective management role, and staff training role as required, for the safe conduct of clinical drug trials to ICH GCP standard.
3. Be aware of Chiltern policies and emergency procedures regarding cardiac arrest, fire and safety.
4. Assist staff in the use and practice of relevant Standard Operating Procedures.
A FULL JOB DESCRIPTION IS AVAILABLE.
QUALIFICATIONS
- Full UK Medical Registration.
- Postgraduate Qualification (e.g. MRCP, MRCGP, etc.)
- Experience in Clinical Pharmacology or a Phase 1 CRO where you have acted as an investigator / co-investigator on Phase 1 studies.
- Good clinical knowledge including up to date ALS certification.
- Good understand the principles underlying the ICH Good Clinical Practice guidelines.
ADDITIONAL INFORMATION
This is a full-time permanent position based in Dundee, Scotland.
Primarily hospital based but some work my involve travel to meeting or attendance at conferences. Overnight stays and or weekend and evening sessions may be required depending upon the workload and nature of current studies.
The Deputy Medical Director will also participate, with other Chiltern Physicians, in the rota to provide 24/7 medical monitoring for studies that require this.
For a confidential discussion about this opportunity, please telephone our Internal Recruitment Manager, Kaushik Pankhania (KP) on +44 (0)1753 216 680. All applications for this position should include a CV and sent to kp@chiltern.com
For more extensive information about Chiltern, please visit our web site at www.chiltern.com
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