Novartis drug Ilaris can reduce arthritis outbreaks

Reuters reported that the Swiss drug maker Novartis released new positive data from two studies of Ilaris, which showed that patients suffering from the most severe form of childhood arthritis were less likely to experience a flare up in the disease.

Systemic juvenile idiopathic arthritis (SJIA) affects less than one child per 100,000. It causes inflammation affecting the whole body, which can involve skin rashes, fever, joint pain and swelling.

Novartis said that the results of a final-stage study showed 62% of patients with SJIA who received Ilaris became symptom-free against 32 percent of those taking a placebo. The results also showed that one third of patients could stop taking steroids within five months of using the drug.

Novartis also said it was on track to submit the drug for regulatory approval for SJIA in both Europe and the United States, based on data from this and other late-stage phase III trials presented last year.

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Bayer Healthcare and Covance announce a long term partnership

Pharmatimes reported that Bayer HealthCare has announced a long-term strategic partnership for clinical drug development with US-based provider CovanceBayer and Covance will work on clinical drug development, including research and development related to Phase II-IV clinical studies and central laboratory services.

Bayer Healthcare  aims to better leverage Covance’s broad range of experience and services across the R&D portfolio to attain best in class operational delivery, efficiency and quality while also delivering significant financial benefits to both organizations.

John Watson, president, strategic partnering, and chief commercial officer at Covance said “We are extremely proud to have established an enduring relationship with Bayer HealthCare built on trust and proven performance that is now elevating to a strategic partnership,”

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Senior Principal Programmer – Basel (Switzerland)

Mylene Paumier is recruiting for a Senior Principal Programmer to join a global pharmaceutical company at their site based in Basel on a permanent basis.

Responsibilities:

As Senior Principal Programmer, you will be responsible for:

  • The integrity of the programming/computing solutions for a major, complex global drug development program with multiple clinical indications/projects or for multiple drug development programs across CSUs within the Franchise 
  • Lead the full execution of final production output generation of quality, timely programming deliverables for CSRs, regulatory submissions/interactions, publications, and market promotions within the drug development program(s) globally 
  • In conjunction with the Biometrician/Statistical Scientist, develop the project-level programming standards and ensure compliance with project-level/disease-area/company standards. Take leadership in supporting the CSU statistician for development of disease-area programming standards, following internal guidelines   
  • Ensure that documents and specifications are consistent and comply with company standards by providing input into eCRFs and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities for the responsible drug projects/program(s)
  • Expert programming leadership for generation of analysis datasets, pooled datasets, listings, tables, figures, listings and Case Report Tabulations for Phase I-IV clinical trials and for regulatory submissions (e.g., SCS, SCE and RMP/safety update) and for other project support (e.g. publications and market promotion) according to established  milestones. Ensure development and usage of highly efficient standard MACROs within the clinical projects/program(s)     
  • In consultation with the Biometrician/Statistical Scientist, responsible for development/update of project-level programming specifications of analysis datasets and pooled datasets (e.g. in  MAP and CSPD) for the clinical drug projects/program(s) 
  • Ensure QC compliance and responsible for program records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality programming deliverables for the drug projects/program(s)
  • Mentor/coach programmers on functional expertise and process for project support across CSUs within the Franchise; Act as a programmer expert for problem-solving in programming/computing aspects within the Franchise.  Act as a programmer expert within the Franchise for  training and/or development of new programming applications 

Qualifications and skills:

As Senior Principal Programmer, you will have the following qualifications, skills and experience:

  • BA/BS/MS equivalent experience in mathematics, statistics, computer science, or health sciences
  • Expert knowledge of / experience with SAS and other relevant programming software 
  • Proven experience in development of advanced MACROs with high programming efficiency; strong programming and problem-solving skills   
  • Proven experience as a strong programmer lead  for clinical project(s)  and submission activities (equivalent)   
  • Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)
  • Proven ability to effectively act as a programmer representative on non-clinical initiatives; proven ability to participate in external Pharma groups on programming related matters (e.g. CDISC)   
  • Work experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry (for MS Statistics / Computer Science graduates). 

Mylene Paumier - Biometrics Recruitment Consultant at CK Clinical

How to apply:

Apply online now:

For more information or to apply for this Senior Principal Programmer position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk. Please quote reference CL24310 in all correspondence.

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CK Clinical welcomes 2 new Recruitment Consultants!

CK Clinical Expand their Biometrics and Regulatory Affairs Recruitment Teams

Due to our great success recruiting for the Pharmaceutical and Biotechnology industries, here at CK Clinical we have expanded our Biometrics and Regulatory Affairs recruitment teams with the appointment of two new Recruitment Consultants – Mylene Paumier and Shreeya Patel.

Meet Mylene – Biometrics Recruitment at CK Clinical

Mylene Paumier - Biometrics Recruitment at CK ClinicalWe are very excited to welcome Mylene Paumier to the CK Clinical Team. Mylene has joined us as  a Recruitment Consultant and will be working along side Priya Mukherjee, specialising in Biometrics recruitment.

Mylene completed her studies in International Business in France at Rouen Business School, during which she spent one year in Japan at Ritsumeikan Asia Pacific University as exchange student. Following this, Mylene completed her Master 2 in International Business at Aston University in the UK.

During her studies, Mylene worked as a recruiter at ExxonMobil as a recruiter for almost one year and focused on recruiting in engineering and business people across France and Europe. After completing her Master 2, Mylene joined Michael Page for 6 months before joining CK Clinical.

Mylene’s big passion is travelling the world, and also enjoying going to the gym, aerobics and fitness.

Meet Shreeya Patel – Regulatory Affairs Recruitment at CK Clinical

Shreeya Patel - Pharmaceutical Regulatory Affairs Recruitment at CK ClinicalWe are also extremely excited to welcome Shreeya to the CK Clinical team. Shreeya has joined us as a Recruitment Consultant specialising in Regulatory Affairs.

Shreeya is a graduate from the University of Manchester where she studied Business Management and German (and loved every minute of it!). Following university, Shreeya worked for a high street recruitment consultancy for 8 months.

In her spare time, Shreeya enjoys socialising with her friends and travelling around the country visiting her friends from University. She also is a big fan of shopping, hitting the gym and watching television.

The team here at CK Clinical wish Mylene and Shreeya a very warm welcome to our team and wish them every success if their new recruitment roles.

Meet the CK Clinical Recruitment TeamClick here to meet the CK Clinical team >

 

 

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Meet Moin Din – Medics Recruitment at CK Clinical

Meet Moin Din, Senior Recruitment Consultant at CK Clinical. Moin specialises in recruiting for Medics and senior level appointments within the Pharmaceutical, CRO, Biotechnology and Healthcare industries.

Moin covers all permanent, interim and contract recruitment within CK Clinical’s Medic Recruitment function. To find out more, please watch Moin’s short video below:

Looking for a Medic job in the Pharmaceutical Industry?

Click here to search our current medic jobs online now.

Alternatively, please call us on +44 (0)1438 743 047 or email info@ckclinical.co.uk.

Click here to meet the rest of the CK Clinical recruitment team.

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Director, Biostatistics – South East

Priya Mukherjee at CK Clinical is currently recruiting for a Director, Biostatistics to join a leading pharmaceutical organisation at their site in the South East.

The Job:

The purpose of this Director,Biostatistics role is to collaboratively produce and support critical data-based evidence for assertions and label claims about medicines through all Phases (I-IV, NIS, IIT) covering biomarkers, efficacy, safety, PRO/QOL and HEOR HEOR for simple and complicated trial designs and challenging analyses.

Responsibilities:

As a Director, Biostatistics you will

  • Handle the day-to-day operational managerial role of single EU Biostatistics team integrated over UK and Germany delivering a regional tactical focus with strong global liaison on a coordinated joint delivery with other regions – across various therapeutic areas including oncology, cardiovascular and metabolic.
  • Through strategic leadership in project teams, you will add value to the company by accelerating worldwide product approvals and enhancing EU product market share and appeal.
  • Enhance functional technical expertise in designing, driving and delivering high quality objective core contributions at the heart of the EU drug development and commercialisation process together with the required ‘state-of-the-art’ regional and global infrastructure.
  • Lead a regional Biostatistics group who oversees all project related biostatistical activities.
  • Develop, directs, prioritises and monitors all statistical programs and processes relevant to clinical trial design, data collection and input, data analysis, data display, QC, and reporting of results with the primary purpose of accelerating worldwide product submissions and investigational product approvals.
  • Oversees and monitors project timelines to ensure established corporate target dates are met.
  • Encourage, monitor, and facilitate biostatistical activities and interactions between international sites, towards the development and implementation of global statistical analysis and reporting standards.
  • Review of all clinical trial protocols, clinical trial reports, and analysis deliverables
  • Ensure quality of all deliverables related to data analysis, display, and reporting of clinical trial results.
  • Provide close interaction with cross-functional groups in the review and selection of CROs; develops and reviews CRO contracts; tracks CRO milestone, timelines, and issues; resolves same.
  • Develop long-range plans for the future of Biostatistics, and monitors metrics and evaluates staff performance. Manages and develops the technical competence and careers of the biostatistical staff.
  • Provide leadership to Biostatistics in setting short-term and long-term departmental, project, and professional goals and objectives.
  • Create momentum, energy, and opportunities for visibility of group within corporate and functional settings.
  • Expand support to new areas and builds new cross-functional relationships while solidifying and enhancing existing relationships.

Qualifications and skills:

The successful application for this Director – Biostatistics job will have the following skills and qualifications:

  • A Ph.D in Statistics, Biostatistics or Mathematics (OR Equivalent).
  • Proven Pharmaceutical Industry experience, together with proven supervisory/management and project management experience.
  • Exposure to vendor risk and performance management, compliance and oversight.
  • Good oral and written communication skills.
  • Proficient in Microsoft Office Suite including Word, Excel, and Project
  • Demonstrated problem solving, analytical, organization, and time management skills
  • Excellent managerial skills; coaches, guides, and professionally develops direct reports
  • Exhibits customer focus, flexibility and team spirit
  • Ability to lead and influence others
  • Demonstrated experience in leading remote teams
  • Ability to function effectively in different cultural settings
  • Proven experience in the implementation of electronic data capture (EDC)

How to apply:Priya Mukherjee - Senior Consultant at CK Clinical

Apply online:

For more information or to apply for this Director – Biostatistics role please contact Priya Mukherjee on 01438 743 047 or email pmukherjee@ckclinical.co.uk. Please quote reference CL24311 in all correspondence.

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Once your CV has been registered with us, one of our specialist Recruitment Consultants will be in contact to discuss your requirements and any relevant jobs we are handling at the moment.

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Pfizer submit plans for $129M expansion in Belgium

Fierce Pharma Manufacturing reported that Pfizer may be planning a $129 million expansion at its manufacturing campus in Puurs, Belgium, which is to be announced next week.

Paul Schoeters of the Christian trade union ACV said that plans for a new manufacturing plant and packaging line have been submitted to the works council. He says about 100 new jobs are anticipated to be created due to the expansion.

The union rep also said “This is a crucial investment if one considers the economic climate. It indicates America’s confidence in Puurs and serves as a tremendous boost for employees here,’

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Senior Regulatory Affairs Officer – Yorkshire

Shreeya Patel at CK Clinical is currently recruiting for a Senior Regulatory Affairs Officer to join a pharmaceutical company at its site in Yorkshire

Responsibilities:

As a Senior Regulatory Affairs Officer you will report to the Principal Regulatory Affairs Officer ans have the following responsibilities:

  • Collate documents and prepare marketing authorisation applications.
  • Prepare packaging in line with EU regulatory guidelines, submissions to external databases and liaising with user test teams.
  • Preparation of type I and II variations.
  • Assessment of PSUR data.
  • Licence preparation, national, MRP and DCP.
  • Prepare, review and submit CTAs.

Qualifications and skills:

The successful candidate for this Senior Regulatory Affairs Officer must have the following skills:

  • Prior experience within regulatory affairs required.
  • Knowledge of CTAs and MAAs.
  • Ability to prioritise workload.
  • Problem solving ability.
  • Attention to detail.

Benefits:

This Senior Regulatory Affairs Officer role will include the following benefits:

  • Bonus scheme
  • Incentive scheme
  • Discounted gym

How to apply:

For more information or to apply for this Senior Regulatory Affairs Officer role, please contact Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk. Please quote reference CL24273 in all correspondence.

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GSK gets approval from FDA for Acne treatment

Pharmatimes reported that GlaxoSmithKline‘s acne treatment Fabior foam has been given approval by regulators in the USA.

The US Food and Drug Administration has approved GSK unit Stiefel’s Fabior (tazarotene) foam. It is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients 12 years of age and older

Acne is the most common skin problem in the US, affecting about 40 – 50 million Americans at any one time. Therefore this is welcome news for those who suffer with the condition.

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Senior Clinical Study Manager Job in London, UK

Russell Oakley at CK Clinical is currently recruiting for a Senior Clinical Study Manager to join a global pharmaceutical manufacturer based in London, UK on a permanent basis.

The company:

This client is a global pharmaceutical manufacturer involved in the development of pharmaceuticals in the therapeutic areas of oncology, diabetes, cardiovascular and hypertension.

Senior Clinical Study Manager Job Description:

As Senior Clinical Study Manager, you will be responsible for  the execution of Phase II and Phase III oncology studies according to ICH guidelines in support of the clinical strategies defined in the Integrated Development Plan (IDP) as they relate to European specific responsibilities. Support of Phase I trials may also be required.

You will be a key member of the oncology clinical team responsible for conducting clinical studies, which includes participating in writing of study protocols; total management of assigned study conduct, including oversight of the study team and CROs/other vendors; identifying and resolving study site issues; managing the study budget and study closeout with a focus on European activities

As Senior Clinical Study Manager, you may also be required to participate in the training of more junior members of staff.

The role will be based in central London but will involve international travel as well as work centred in the UK.

Qualifications, Skills and Experience:

The ideal candidate for this Senior Clinical Study Manager, you will have the following qualifications, skills and experience:

  • Bachelors Degree preferably in Life Sciences, or R.N., or international equivalent.
  • Demonstrable clinical trial management experience including accumulation of one year of monitoring experience required.
  • Demonstrated ability to manage multiple clinical trials on time and within budget.
  • Superior communication skills: written, oral, interpersonal and presentation.
  • Excellent problem solving and analytical skills.
  • Must work effectively in a cross-cultural matrix team environment and be flexible to contribute to the needs of the group.
  • Clear, direct, tactful communication skills are required.
  • Good writing skills with experience in writing study protocols, summaries, clinical brochures, FDA annual reports and other clinical documents for submission to the FDA. Writing should be clear, concise and accurately represent findings.
  • Strategic thinking – Begin to participate in strategic planning. Able to anticipate potential problems and obstacles and plan accordingly.
  • Ability to organize and manage a CRO and multiple sites participating in a clinical trial.
  • Ability to prioritize work effectively to meet timelines.
  • Demonstrates professional and effective presentation skills.
  • Analytical skills – ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
  • Responsible for resolving issues with study conduct with appropriate staff, CRO and study sites for a clinical study.
  • Solid judgment is required before applying the solutions program wide.
  • Good judgment, professionalism and independence are needed in interfacing with staff, CROs, study coordinators, and investigators Interpersonal Flexibility – ability to adapt to other personalities and cultural differences, in a respectful manner that is conducive to goal achievement
  • Resource Management – ability to manage internal and external vendor resources related to study trial conduct.

The following skills are not essential but would be desirable for this Senior Clinical Study Manager position:

  • In depth knowledge of oncology clinical trials.
  • Familiarity with MS Outlook, Word, Excel, etc.
  • Participation in NDA/CTD process

How to apply:

Russell Oakley - Senior Consultant at CK Clinical
Please contact Russell for more details.

Click here to apply online now.

For more information regarding this Senior Clinical Study Manager job in London, please contact Russell Oakley at CK Clinical on +44 (0) 114 283 9956 or email roakley@ckscience.co.uk. Please quote reference CL24219 in all correspondence.

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