James Kennelly

Experience

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  University of York Cancer Research Unit

  Sept 1980 - Mar 1984

  Post-Doctoral Research Fellow

  Researching mechanisms of chemical carcinogenesis, (aromatic amines and benzidine-based azodyes).Achievements: * Delivered first paper on Benzidine project for publication within 3 months of joining unit

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  Microtest Research Ltd

  Apr 1984 - May 1989

  Coordinator of Short Term Tests

  Managing a team of 10-12 scientists conducting contract studies for potential carcinogenicity. Achievements: * Delivery of studies to time and budget essential for company survival during its first years

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  ICI/Zeneca Central Toxicology Laboratory

  Jun 1989 - Mar 1994

  Manager, Mammalian Genotoxicity

  Providing of genotoxicity advice and testing services. Managing a team of 8 scientists, processing 25 compounds per year. Devising and managing the strategic method development programme of the Genetic Toxicology Unit, evaluating direct-acting carcinogens. Achievements: * Resolved service and quality problems of complex laboratory processes. A technique considered a logjam for development became a robust reliable and routine assay.* An excellent record of customer service, shown by studies both to time (none late for 4 years) and accurately costed (delivered at 95% of quote).* Reduced cost of assays to ICI/Zeneca sponsors by 20%* Doubled productivity of group in 3 years* Independently evaluated controversial stomach carcinogen assay to resolve dispute between Astra and Glaxo concerning potential risk of Omeprazole. Omeprazole continued on to be one of the World’s most widely used pharmaceuticals* Chairman of the United Kingdom Environmental Mutagen Society (UKEMS) working party, managed the production of an authoritative guideline on the liver UDS system. * As GLP coordinator, initiated a programme of improvements across all groups to ensure compliance with Department of Health regulations. During two DOH GLP inspections at CTL, the inspectors singled out our Section for favourable comment Show less

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  Zeneca UK

  Mar 1994 - Jan 1999

  UK Clinical project manager for Accolate; Presenting clinical data in response to queries from medical information, for sales force training and at external symposia. Delivery of work via CROs. Liaison with Drug Safety Unit (University of Southampton) for independent evaluation of Accolate safetyAchievements: * Delivery of the Accolate safety study, the largest AZ study wholly within UK (6,500 subjects), was key to the maintenance of the registration of the product. * Annual reports to MCA addressed longstanding safety concerns* Core member of UK Respiratory development team.* Invited external representative on Award Committee for BSc in Biomedical Sciences at University of Wolverhampton Show less Cross-functional working to formulating drug development plans through to launch for products currently at preclinical to phase II development. Delivering studies via directly managed CRAsAchievements: * Recommended prompt closure of chronic heart failure candidate programme in the face of adverse toxicological data with significant saving of development budgets* Close liaison with Zeneca staff and other pharmaceutical companies enabled the resolution of doubts concerning endothelin antagonist and the justified continuation of development of the product Show less Monitoring and managing international studies within the phase 3 and phase 4 development of Accolate. Delivering studies via managed CROsAchievements: * Devised centralised tracking system of patient entry to report to management. Still in use 3 years after departure from the team* Novel application of Patient event recording technology to provide essential compliance data for Accolate product launch.* Developed the role and responsibilities of Administrative Assistants within the team to address high CRA workloads in the ACCOLATE programme. The ACCOLATE Administrative Assistant model was then adopted across other Drug Teams in the Medical Function. Show less

  • Clinical Projects Manager

    Jan 1998 - Jan 1999

  • International Clinical Research Associate/Project Leader, Exploratory Group

    Jan 1997 - Jan 1998

  • Clinical Research Associate Respiratory Team, MRD/MAD

    Mar 1994 - Jan 1997
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  AstraZeneca UK

  Feb 1999 - Dec 2003

  Delivering all UK clinical work in the respiratory therapy area approximately 16 concurrent studies each year involving, 4-5 products, budget of £5M/year; providing project management support to study managers. Vetting and selecting CROs. Therapeutic and product training of clinical and sales teams; directly managing high priority or high value projects.Achievements:* Delivered the Symbicort ASSURE 1700 patient megatrial to time and budget. The most successful launch study ever for an AstraZeneca UK product in terms of reach to investigators (305 centres), useable data and total production of papers and presentations (12 up to 2003).* Invited member of international Symbicort Scientific steering committee. Show less

  • Respiratory Clinical Research Project Manager

    Feb 2000 - Dec 2003

  • Oncology Project Manager

    Feb 1999 - Feb 2000
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  Kendle International

  Mar 2004 - Oct 2005

  Project Leader

  Particular interest in Respiratory Development, Oncology and large multinational trials. Developing and defending bids from assigned requests for proposals (RFP) and functioning as an integral part of the selling team. Line managing 5 UK clinical staff, responsible for performance management and development. Liaising with the customer and third party contractors.Achievements:* 56% success rate in bid defences compared with global company average of 16%.* Reorganised costing of bids, so total price was no longer a barrier to acceptance. This was essential for the turnaround of new business successes in the European office* Restructured performance targets for staff to bring in measurable, ie SMART targets; adopted throughout UK organisation; excellent feedback on the effect of these changes. Show less

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  Quintiles

  Oct 2005 - May 2006

  Project Director

  Managing of project activities and project team members. Focal point for communicating between sponsor and Quintiles. Responsible for managing, timelines, quality and costs of projects. Achievements: * Winning $100M respiratory programme contract for Quintiles; own credibility as Project Director was cited a major factor in this bid success, biggest win for several years at Quintiles.* Identified structural issues that would enable phase I unit to conduct phase II studies as a future funding stream. This was essential for the very survival of the unit within Quintiles Show less

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  ICON Clinical Research

  Jun 2006 - Dec 2010

  Senior Project Manager

  Delivering clinical trial projects to time, specification and budget. Liaising with customers and third party contractors. Co-ordinating and managing service lines; Regulatory Affairs, Study Drug Management, Safety Surveillance & Reporting, Clinical Monitoring/Site Management, Data Management, Bio-statistics and Medical. Line managing clinical staff with majority of FTE allocated to assigned projects; currently 7 staff at all levels in 4 countries.Achievements: * Delivered robust result in pivotal multinational study despite the absence of agreed sponsor data surveillance, retrieving a potentially catastrophic lack of compliance* External audits of 3 studies' data revealed no critical findings. Show less

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  REGISTRAT MAPI

  Mar 2011 - Feb 2012

  Project Director

  Project Director responsible for the overall coordination and management of assigned post marketing studies for one or more clients. As the team leader, ensures assigned studies are delivered successfully, on-time, within budget, according to client expectations and with the highest quality possible.Achievements:* Delivering programmes of studies in oncology, metabolic disease and diabetes assessing safety, epidemiology and QOL endpoints

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  Ancona Alpha Research Services

  Mar 2012 - now

  Director

  Over 20 years’ experience, providing Project Management and Consultancy to the Pharmaceutical and Allied Industries; Working with Biotech, CROs and major Pharma companies. Providing an extensive range of professional services for drug development; Programme planning, project planning, protocol writing and development, business development support, client relationship management, delivery management, quality, resource and budgetary control, compliance, line management, training, liaison with external scientific and safety committees, clinical report writing, writing of scientific papers, medical communications and presentations Show less