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Associate Director/Director Clinical Sci
4 months ago
CELLDEX THERAPEUTICS INC
Associate Director/Director Clinical Sci
Fall River ,
Massachusetts
Apply Now
Overview Join a growing Clinical Science team where you will workdirectly with the VP, Clinical Science. You will support Celldexsclinical development programs by contributing to the design, datacollection, and reporting of clinical studies in a manner consistentwith industry standards, applicable regulations and clinical developmentstrategy. This position assembles, interprets, and presents scientificand medical data. Responsibilities will also include evaluation ofclinical outcome measures, data review and trial startup activities.Responsibilities Working with CMO, VP, Clinical Science and medicaldirectors, contribute to the development of clinicalprotocols/amendments by performing literature review/analysis andsoliciting input from medical, statistical and operational, as well aspre-clinical, resources. Ensure clinical data collection proceeds in amanner consistent with strategic objectives and regulatory requirementsfor reporting (i.e., collaborate with statisticians to producestatistical analysis plans and data displays; provide input to CRFdesign and data management processes; perform periodic review ofclinical data). Participate in planning for interim data analyses andreviews, including Data Safety Monitoring Board (DSMB) meetings. Workingwith the medical director, monitor and evaluate emerging clinical data.Review/interpret data to produce strategically relevant abstracts,presentations and manuscripts. Author (and/or work with medical writerto develop) clinical documents including but not limited to: clinicalprotocols, briefing documents, IND annual reports, Investigator\'sBrochures, clinical protocols and amendments, clinical study reports,scientific manuscripts and abstracts, posters and scientificpresentations. Qualifications 5-10 years of experience in clinicalresearch setting, including medical writing and oversight of (or closecollaboration with) data management/analysis/reporting functions. MS/MAdegree or equivalent in a scientific or health care field required. PhDspreferred. Experience authoring clinical protocols, regulatory documents(IND sections, clinical study reports, investigator brochures), as wellas scientific publication and presentations. Ability to collaborativelydevelop relationships with physicians, expert consultants, andcontracted vendors. At least 2 years of experience in immunology &inflammation preferred. Strong analytical mind, excellent written/verbalcommunication skills, attention to detail, organizational skills, andability to work independently and as part of a team. Strong documentmanagement skills, including proficiency with MS Office Suite. Strongmedical writing skills: takes ownership of document, organizes timeline,works with other co-authors, resolves discrepancies and edits to achieveconsistency, uses precise accurate language and grammar Knowledge andexperience in clinical development Ability to multitask to meettimelines under changing conditions.
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