Director, Clinical Science

  • Location:Cambridge,MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Senior Manager/Supervisor

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 assigned

 

EDUCATION 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.)
  • 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 preferred