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Theravance’s shareholders have approved the transaction which will see the UK drug major buy 10 million shares priced at $21.29 apiece. This means GSK now owns about 25.8 million shares in  Theravance’s.

The companies have been partners for nearly ten years and have developed Relovair, which combines a once-daily inhaled corticosteroid (fluticasone) with a long-acting beta-agonist (vilanterol). Phase III development has been completed and GSK intends to submit regulatory applications for chronic obstructive pulmonary disease in the USA and Europe in mid-2012.

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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:

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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Janssen Cilag is one of the world’s leading research-based pharmaceutical companies, and the prostate cancer drug that they manufacture, Abirateron has been shown to extend the lives of late-stage prostate cancer sufferers by more than three months.

The National Institute for Health and Clinical Excellence (NICE) have revised their recommendations and prostate cancer drug is now approved for used by the National Health Service. Janssen will be providing the prostate cancer drug to the NHS at a discounted price.

Developed by the Institute of Cancer Research, the prostate cancer drug took two decades to develop, as Professor Alan Ashworth explains, ”This drug was discovered at the Institute of Cancer Research and is the result of more than two decades of dedicated work by our scientists and collaborators.

“In clinical trials of men with advanced prostate cancer who have already tried chemotherapy, it has been shown to extend life by an average of four months and improve quality of life.”

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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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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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Pharmatimes

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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Responsibilities:

As Data Manager the main purpose of your role will be to:

• Provide timely and professional ongoing management of project & clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines
• Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s)
• Ensure consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects
• Have business understanding of the compound profile (CDP/TPP) to identify and assist in successful application of data management processes
• Respond to Health Authority requests for data management issues
• Support and assist Assistant Data Managers and other Data Managers for allocated trials within assigned project(s)
• Provide input, review, and maintenance of global working practices and standards
• Contribute to the development of the Data Management organization through his/her leadership role within the DM Group
• Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases
• Ensure appropriate company tracking systems are up to date and accurate
• Lead and support clinical & non-clinical special projects
• May deputize for Data Management Group Head and assist in coaching, training and mentoring of Data Management staff.

Qualifications and skills:

As Data Manager, you will have the following qualifications, skills and experience:

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• Languages: Fluent English (oral and written) and French
• Ideally 5 or more years experience in drug development, with at least 4 years in Data Management activities
• Project team leadership experience required
• Good technical and problem solving skills
• Thorough understanding of clinical trial methodology, GCP and medical terminology
• Ability to work independently, under pressure, demonstrating initiative and flexibility
• Attention to detail and quality focused
• Good organizational, planning and project management skills
• Good interpersonal and communication skills and ability to operate effectively in an international environment
• Good negotiation skills
• Thorough understanding of physiology, pharmacology, clinical study objectives and the drug development process
• Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.

How to apply:

Apply online:

For more information or to apply for this Data Manager position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk. Please quote reference CL24263 in all correspondence.

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Approximately 700,000 people in the UK suffer with chronic migraines, which typically cause nausea and sensitivity to light and sound. To be classed as chronic migraines, a patient must have headaches on at least 15 days a month, 8 of which have to be migraines.

It is thought that the botox treatment, developed by Allergan, the global speciality pharmaceutical company, may be effective as it helps to block the pain signals and relaxes muscles.

Back in February 2012, NICE rejected the botox treatment as it did not see enough evidence to justify its approval. In a turnaround, NICE are now backing its use in those chronic migraine patients who has not been helped by the use of at least three previous medications. They are expected to issue final guidelines in June 2012.

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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:

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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