Drug failure rates on the rise in Phase II and III clinical trials

As reported by, Med City News, according to a recent analysis by the Centre for Medicines Research in the UK, since 2008, drug failure rates have been steadily rising in Phase II and III clinical trials.

The analysis found that sixty-eight per cent of Phase  II failures between 2008 and 2010 fell into five therapeutic areas:

  1. Alimentary/metabolism (including diabetes) (23%)
  2. Cancer (20%)
  3. Neurological disorders (16%)
  4. Cardiovascular diseases (11%)
  5. Other (32%)

 

When looking at Phase III clinical trials, the study found that the failure rate is at approximately fifty per cent – this has risen since 2007. These failures fell into the same therapeutic areas as outlined above.  Sixty-six percent of these failures were due to lack of efficacy, while twenty-one percent failed due to concerns with safety.

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Associate Director of Global QA– Home Counties

An Associate Director of Global QA is sought to work from the UK office of a very successful global pharmaceutical company based in the Home Counties.

Responsibilities:

You will have responsibility for the implementation and delivery of audit programs covering GCP, PV and IT, working at both global and local affiliate levels. A key aspect of this role will be personnel management and development, you will manage a team of up to eight auditors.

Requirements:

  • A thorough knowledge of national and international regulations pertaining to GCP, Pharmacovigilance and IT compliance regulations
  • Extensive experience gained within pharmaceutical compliance
  • Proven line management skills, able to train, supervise and develop staff
  • Willingness to travel nationally and internationally, up to 30%

 

How to apply

For more information or to apply for this Associate Director position, please contact Jim Gleeson at CK Clinical on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL21767 in all correspondence.

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Parexel and Icon to provide Pfizer with clinical development services

As reported by Outsourcing Pharma, Parexel and Icon will be providing the US pharma company, Pfizer, with clinical development services as part of a five-year agreement that will begin next month. This marks the latest of a number of strategic partnerships by CRO’s.

Speaking of the agreement, Parexel CEO Josef von Rickenback stated,  “Pfizer has engaged Parexel in a strategic partnership model and we have been selected as one of only two strategic partners that will handle their clinical development needs over the next five years.”

Parexel will leverage its proven clinical processes and expertise combined with its market-leading eClinical technology platform. This will help Pfizer gain greater visibility into trials and improve data access for faster, better decision making.”

This is Parexel’s fouth strategic partnership – following agreements with top pharma companies such as GSK, Eli Lilly and Bristol Myers Squibb.

Are you looking for your next role in the pharmaceutical industry? Click here to search our current pharmaceutical jobs online now.

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GSK gains European approval for epilepsy drug

As reported by The Pharma Times, GlaxoSmithKline (GSK) gained European approval for their epilepsy drug, Trobalt.

The drug is unique in that it acts faster than existing treatments, taking effect as little as 90 minutes after being taken. It is designed to help suffers of epilepsy gain greater control over their seizures.

European approval for the drug came as a result of two pivotal phase 2 studies. These studies highlighted a significant improvement in seizure control, with patients experiencing on average, 50% less seizures when compared to the placebo.

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Clinical Education Manager Job (Permanent) – Berkshire, UK

CK Clinical are recruiting for a Clinical Education Manager to join an established Pharmaceutical company in Berkshire.

You will be working as an integral part of the Renal Marketing team. In your daily activities you will support the Medical Affairs department in the management of all renal research programmes and key opinion leader development in the UK, in line with the renal marketing plans. You will act as clinical expert and support the regional account teams and clinical managers.

Key Responsibilities:

  • Lead, develop and manage all renal clinical education programmes in the support the regional account teams with bespoke training programmes for Nephrology SpRs and Renal Nurses.
  • Support and facilitate the growth and development of the Kidney Education Network in collaboration with the committee.
  • Develop and maintain innovative educational programmes for home dialysis therapies utilising on-line and digital platforms including on-line PD academy and the “I’d rather be at home” website.
  • Map current key opinion leaders for Home Dialysis therapies and identify future directions for their development.
  • Identify recently appointed nephrologists and nurses who could be developed as key opinion leaders.
  • Design development plans for individual key opinion leaders in line with business requirements and strategy and together with account teams and marketing colleagues implement these plans.
  • Together with the Medical Affairs department and marketing team, assist in the development, implementation and follow-up of medical advisory boards.
  • In conjunction with Medical Affairs ensure on-going management of company funded research projects.
  • Raise awareness in the renal community of the CEC and EMGP grant application processes.
  • Continually review and evaluate on-going research in the UK renal community and globally to ensure appropriate communication of relevant studies and collaboration where appropriate.
  • Manage and develop the Unplanned Start Patient Education Programme (UPS).
  • Together with European Marketing, develop the existing UPS tools to be appropriate for use in planned start patients.
  • Maintain, develop and gain ABPI approval for patient education tools as required and in line with UK marketing strategy.
  • Development and execution of marketing powerhouse plan together with marketing team.
  • Marketing support to Assisted APD programme.
  • Dissemination of marketing plans to field teams via National Sales meetings and regional account planning meetings.
  • Internal training for all Renal team (new and existing) as required.
  • Support with meetings and conferences.
  • Support clinical team with CQI programmes.
  • Development and updating of patient education materials as required.
  • Budget responsibility for all clinical education programmes.

 

Benefits:

Successful candidates will enjoy the benefits of working with a global Pharmaceutical company, including a COMPETITIVE SALARY, HOLIDAYS, and CAREER PROGRESSION.

Qualifications:

  • Science degree or equivalent.
  • Nephrology nursing or medical qualification.

 

Apply Now

For more information or to apply for this Clinical Education Manager job, please contact Hendre Moolman at CK Clinical on 01438 870 023 or email hmoolman@ckclinical.co.uk.

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Novartis to Reduce UK Drug Development

As reported by the BBC, The Swiss-based pharmaceutical company, Novartis are reportedly planning to close their drug development and manufacturing operations in Horsham, West Sussex.

This site currently employees 950 staff and this is set to reduce to 400 within just two years. It produces approximately 60 different formulations of drugs. Staff will be retained who work on developing respiratory drugs in Horsham. Those focused on gastrointestinal medicines will be relocated to their units based in Cambridge, Massachusetts and Basel in Switzerland.

The announcement comes after a series of cuts by pharmaceutical companies across the UK. Including, Pfizer who are to close their research and development centre in Sandwich, Kent – potentially cutting up to 2,400 posts. In addition, both AstraZeneca and GlaxoSmithKline are shutting down sites across the UK.

Novartis have disputed the notion that their plans to close the Horsham site is linked to the decline in attractiveness of the UK in terms of innovation. General Manager, Sue Webb stated, “With significant changes in healthcare systems aimed to contain or cut cost, this critical assessment and the subsequent potential changes to the Novartis UK organisation are key to maintain significant investment in innovative drugs and our research efforts in the UK.”

The Swiss-based pharmaceutical company plan to maintain their manufacturing sites based in Grimsby, Liverpool and Dundee.

Are you looking for a new position in the UK Pharmaceutical Industry? Click here to search our current jobs now.

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CK Clinical to Exhibit at the ICR Conference 2011

CK Clinical are proud to announce that we will be exhibiting at the ICR 32nd Annual Conference on the 21st – 22nd March at the Brighton Hilton Metropole.

Here at CK Clinical we are big fans of the ICR Conference as it provides a great opportunity to not only learn about the latest developments in clinical research and but also to network with professionals in the area.

Our specialist Consultants Jim Gleeson and Ben Traies will be representing CK Clinical at the event. Please come and say hello, our stand number will be 35. If you would like to schedule in a meeting to discuss possible recruitment requirements or job opportunities, please email Jim at jgleeson@ckclinical.co.uk.

We look forward to seeing you there!

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Our Current Clinical Jobs…

Are you looking for a new position in the pharmaceutical industry? CK Clinical can help you.

We are the specialists in clinical recruitment and are currently recruiting for the following positions:

 

  • Senior Clinical Quality Assurance Auditor, London

An experienced GCP auditor is required for this permanent role in which you will audit clinical trial sites and laboratories in support of early phase oncology studies. GCLP experience will be advantageous.

  • Clinical Research Nurses, North West

A large number or Research Nurses are required to support a major study with a large, global pharmaceutical company. These will be long term contract positions at good daily rates.

 

  • Senior CRA, Home Counties

A permanent position with a US biotechnology company to monitor orphan disease studies in the UK and Europe. Candidates will require strong monitoring experience and must be willing to travel extensively.

 

  • Clinical Research Scientist, London

A long term contract position with a blue chip pharmaceutical company. Suitable for an experienced CRA or SCRA, this role will involve site monitoring and project management for complex vaccine studies.

 

  • Clinical Supply Coordinator, Cambridge

Working for a very successful biotechnology company you will coordinate packaging and labelling activities for Clinical Trial Materials being used in global studies. A permanent role with good salary and benefits package.

 

  • Senior Associate Study Management, Cambridge or Uxbridge

An excellent opportunity for a Lead CRA/Junior Clinical Project Manager to progress into a junior Study Management role. Based in Cambridge or Uxbridge, you will be employed under an initial 12 month contract.

For more details regarding any of the positions outlined above, please contact Jim Gleeson at CK Clinical on 01438 743 047 or email jgleeson@ckclinical.co.uk.

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Senior Data Manager Job

Department: Global Development Operations Department

In this role you will:

  • Participate in study teams and all related meetings for assigned protocols
  • Prepare documents and ensure tools are arranged to allow for data capture and data cleaning
  • Ensure delivery of a clean database
  • Run and oversee a project or set of studies within a project under supervision of a higher level data manager, which may include outsourcing and CRO oversight for studies for which Data Management activities are done by a CRO
  • Instruct, communicate and coach others on data management procedures (lower level data managers, but also providing training to and creating guidelines for monitors and site staff/ investigators)
  • Ensure compliance with EMEA, FDA and ICH regulations and policies, including validation deliverables

Your personal qualifications:

  • BS/BA degree in a biological science, health-related, or computer science field.
  • 7-10 years related experience in pharmaceutical, clinical research or health services industry with at least 4 years of experience with Data Management in the pharmaceutical industry
  • Demonstrated knowledge of medical terminology, personal computers, database structures and database management software
  • Problem solving attitude and analytical skills
  • Capable to work in multidisciplinary and international teams
  • Excellent communication, planning & organizing skills
  • Experience in working with EDC/ePRO tools

For more information, please contact Priya Mukherjee at CK Clinical on 01438 743 047 or email pmukherjee@ckclinical.co.uk.

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So You’ve Just had Your Interview…What Next?

iStock_000003154367MediumSo you’ve just walked out of your interview, you breathe a sigh of relief, kick back and relax. But be warned – the hard work isn’t over yet! Here are a few hints to help you follow up your interview like a true professional and give you the edge over your competitors:

  • Ask the interviewer when they are planning to make a decision.
  • Thank the interviewer for their time.
  • Whilst you are waiting for feedback – continue with your job search.
  • Write a short and polite thank you note to the employer/recruitment consultant – make sure you don’t make any spelling mistakes!
  • After your interview, take some quiet time to sit and write down your thoughts regarding the interview – this will help you to analyse the interview and see where you could make improvements next time.
  • Give your Recruitment Consultant a call to tell them how the interview went and take this opportunity to reiterate to them how interested you are in the role.
  • Don’t panic if you don’t hear back from the employer or your Recruitment Consultant immediately.

 

Found this useful? See below for more helpful careers advice from CK Clinical:

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