Director Clinical Science
Company: Surface Oncology Inc.
Location: Cambridge
Posted on: February 23, 2021
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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
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Keywords: Surface Oncology Inc., Cambridge , Director Clinical Science, Executive , Cambridge, Massachusetts
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