Director Clinical Science

Company: Surface Oncology Inc.
Location: Cambridge
Posted on: February 23, 2021

Job Description:

Director, Clinical Science RESPONSIBILITIES:* Contributes to the clinical development strategy and operational plans working as part of an integrated drug development team* Contributes to the development of the clinical study design and writing of the study synopsis and protocol* Contributes to clinical development plans, clinical sections and review of other study related documentation (Investigator's Brochure, Scientific Rationales/Justification, Regulatory agency briefing documents and responses to questions, Clinical Study Reports)* Works with clinical sites to answer protocol related questions, resolve study conduct and design issues* Contributes to the development of and participates in Investigator Meetings, Study Initiation Visits, and Advisory Boards as appropriate* Reviews data listings, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and follows up as appropriate* Involved in analysis of data for regulatory submissions, presentations, publications, and study designs* Assists in review of all adverse experience reports for accuracy and clinical importance, characterization of severity, seriousness, and relationship to the study drug* Works closely with other functions such as safety, biostatistics, data management, and regulatory affairs to provide accurate reports to FDA or other regulatory agencies* Presents findings internally and externally (such as investigator meetings), acting as a spokesperson for the company relating to the trial/indication* Attends scientific meetings to stay current on new developments within relevant areas* Other duties as assignedEDUCATION AND EXPERIENCE: * At least 2 years of oncology drug development experience* Advanced degree in biological sciences or health-related field is required (e.g. Ph.D., Pharm. D, M.S.N, M.P.H., PA, NP)* Experience operating independently implementing clinical trials* Collaborative team player with excellent interpersonal and communication skills* Ability to strategically and proactively think and lead in interdisciplinary teams* Experience in data analysis and interpretation* Experience in immuno-oncology preferredPowered by JazzHRQICQnh5QtA

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