
Skills & Expertise
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Record of a focus on results with demonstrated drive to meet targets and act decisively to ensure completion of projects and growth of business.
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Team builder.
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Problem solver.
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Experience directing a portfolio of clinical trial projects or programs through others.
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Experience with direct-line management of others in a drug development environment.
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Strategic/big-picture thinker.
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Program management experience including directing activities in non-clinical, CMC, regulatory, first-in-human, pharmacology, biomarkers, proof-of-concept, and pivotal clinical trials.
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Experience in multiple therapeutic areas.
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Excellent organizational skills with the ability to manage multiple and varied tasks and prioritize workload.
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Comfortable working with multiple stakeholders in a matrix and global environment.
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Broad business expertise including budget management, strategic planning, and revenue forecasting.
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Strong business acumen and skills in matters related to resource management and revenue enhancement.
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Excellent presentation, persuasive verbal and written communication skills, with ability to influence others.
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Solid knowledge of industry regulatory laws, ICH regulations, and GXP.
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Experience preparing INDs and NDAs, including FDA meeting packages and FDA meetings
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Extensive pharmaceutical experience negotiating with and directing vendors and CROs.
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Flexibility with respect to work assignments, new learning and travel.