Director, Clinical Science

The Director, Clinical Science interacts within a multi-disciplinary, matrix environment, ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall development plans. While in this role, you will have the opportunity to be the lead clinical scientist for Clinical Development and Clinical Pharmacology studies of one or more programs.Responsibilities include contributions to writing and review of clinical documents, supporting operationalization of studies, monitoring data in real time to ensure integrity of study endpoints, proactively identifying issues in the conduct of trials, and medical review and analysis of data for the purposes of data cleaning and interpretation for regulatory documents and publications.This position will report to the Senior Medical Director, Clinical Development and work on-site at our Waltham, MA office or remotely. For Waltham employees Deciphera expects a minimum number of three days a week on site, with flexibility as to hours on site on any given day to accommodate work/life balance. Specific days and times spent in the office should be determined in conjunction with your manager.What You’ll Do:Works closely with Medical Directors, Clinical Pharmacology, Translational Research, Discovery, Data Management external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans.Assists in the development of concept sheets/decks for clinical studies; contributes to authoring of clinical study protocols, amendments and related documents, as well as clinical sections of regulatory documents (IB, IND sections).Contributes to clinical sections of study-related regulatory submissions and responses to regulatory queries.Monitors real time study data to ensure study integrity; interacts with investigators and internal and external experts to resolve any study issues. Responsible for high level data cleaning activities requiring clinical judgment.Will act as the primary point of contact between clinical science and data management, advice in EDC builds.Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs.Clinical/scientific subject matter expert on products and studies in the therapeutic area.May act as the medical Study Lead for ongoing clinical or clinical pharmacology studies.Prepares data for and leads key study meetings including site safety calls and investigator meetings.Contributes to preparation of abstracts, manuscripts, and presentations for external meetings.Attends scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators and advisors.May present data, protocol designs and other information at advisory boards, investigator meetings, steering committees, site initiations and other internal and external settings.Act as a functional leader across wider clinical scientist group with responsibility to mentor, coordinate, and act as a point of escalation and liaison across functions and with management. Achieve and maintain consistency in clinical scientist practices across studies by leading the CS team.