Senior Director Clinical Operations
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate.
20+ years of experience in clinical trial Phases I - IV, including first in man, pivotal trials and post-marketing efforts across therapeutic areas including: oncology, Anti-infectives [UTI (including geriatric and pediatric), chronic bronchitis, sinusitis, pneumonia, and intra-abdominal infection], neurology (sleep, early Parkinson’s Disease, Huntington’s Disease and Restless Legs Syndrome), metabolics and men's healthSpecialties: -Skilled in CRO / external vendor qualification, selection, contract / budget negotiation, & management. -Staff selection, training and development -Excellent oral & written communicator w/ experience in review and development of protocols, CSRs, IBs, contributions to INDs, ISS and ISE documents, annual reports to FDA, abstracts, publications and scientific posters -Creative problem solver with a keen attention to detail and refined organizational skills
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