Clinical Trial Head, Oncology

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Amar Annamalai
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Clinical Trial Head, Oncology

Job Description:
Accountable for all aspects of assigned OTM clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT)
Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL)
Contribute to the development of clinical sections of regulatory documents, lead or be a key contributor to the development of program specific standards
Investigator/site relationship management
Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements
In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation
Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties
Function as local trial leader (LTL) for all US US-based CTL activities

 
Minimum Requirements:
 
Advanced degree or equivalent education/degree in life science/healthcare strongly recommended, PhD preferred
Fluent English (oral and written)
≥ 6 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process
Advanced knowledge of oncology and/or hematology, or experience in early clinical development

Deadline: September 19, 2013

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