| 7 March 2010 |
| Global Clinical Lead |
|
Company Description:
Advanced Clinical Recruitment is a specialist recruitment service, whose only focus is to supply candidates to the Pharmaceutical industry. We have ongoing positions available with the worlds largest Biotech/Pharmas & CROs in Western/Eastern Europe & the world. Our service is of the highest standard & with over 10 years experience in the industry we can offer a considerate & comprehensive recruitment process. Funtion Description: Senior role to provide leadership in a growing Allergy & Respiratory disease area. Ensures that appropriate medical and scientific expertise is brought to the clinical trial strategy and execution of the clinical program, including oversight of clinical trial safety review, and analysis and tracking of emerging efficacy and safety profile of the drugs. Other Requirements: The candidate will be responsible for : Accountable for design and final recommendations for clinical plans for compounds / indications overseen by their respective Medicine Management Team Accountable for negotiating milestones and ensuring execution and delivery of the clinical plan in line with agreed timelines. Leads the Global Clinical Team to design, execute and interpret post proof of concept (POC) studies Acquires knowledge of competitor products and clinical plans, and maintains and enhances knowledge in relevant therapeutic or technical areas Plans resources required both within the Primary Medicines Development Group and in conjunction with PGRD lines to accomplish the clinical objectives in a timely and resource-efficient fashion, including consideration of FTEs and operational resourcing Responsible for developing, recommending, getting approval, and adhering to the clinical trial budget Leads a motivated, committed and engaged Global Clinical Team towards the common goal of submissions of approvable regulatory filings that meet customer needs (patient, prescriber, health technology assessment), and/or in the conduct of peri- and post-approval studies which clearly establish the value or clarify the risk:benefit profile of the Medicine. Models, expects and ensures effective team behavior to achieve the program goals Leads clinical preparation for, and attends, important meetings with regulatory agencies worldwide, together with other relevant colleagues from the Global Clinical Team and Medicines Team Leads preparations and presentation of the clinical content of regulatory submissions/documents Accountable for ensuring regulatory compliance for clinical trials and reporting Ensures seamless transition from Research to PC BU for drugs that have achieved proof of concept Accountable for keeping Medicine Team Lead and Clinical Group Head informed of clinical progress and any critical clinical issues, especially the emerging safety profile Accountable for input and approval of clinical documents: protocols, IBs, study reports, statistical analysis plans, publications, clinical sections of submissions (in conjunction with senior medical monitor if necessary) Accountable for clinical expert panel meetings and advisory boards to give input on clinical plans Presents to senior management and external audiences on clinical aspects of projects: including milestones, strategies, data Contributes to high quality clinical review of post-POC licensing opportunities, coordinating clinical focused technical due diligence if required. Involves internal disease area experts (eg Clinical Disease Area Expert) and consults with relevant technical advisory committee(s) to ensure high quality and efficient clinical development plans and protocol designs that reflect enhanced clinical trial design (ECTD) principles, enhanced quantitative drug development (EQDD) principles, and current disease area knowledge, with an eye on continuous improvement. As line manager for BU clinicians, ensures excellence in support for the BU through education, training, mentorship and performance management; this includes challenging every CPL and clinical scientist to design clinical plans and studies that improve the efficiency (value:cost ratio) of the project. May also fulfill role of clinical program lead (CPL), clinical scientist, medical monitor M.D. ,PhD, DVM and/or Pharm.D. or equivalent qualification Demonstrated expertise in managing global clinical programs in late phase development or post-approval in the pharmaceutical industry Expertise in the relevant disease area (Respiratory) Expertise in managing large clinical programs in industry Demonstrated strong collaboration with Development Operations colleagues Offer: Work location: To apply, please send your CV to jholland@acr-uk.com |
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