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Position:
SR/Clinical Research Scientist - Clinical Development - Oncology 

Employer:
Boston Biomedical Inc

Description:

The SR. Clinical Scientist role is an exciting opportunity for a highly motivated individual to be a key contributor to the development and execution of the clinical strategy for one or more oncology programs. Through extensive interaction with the Clinical Development Team, you will have opportunities to make strategic and scientific impact on current and future Clinical Programs, building clinical expertise to collaboratively design, plan, implement, analyze, and report clinical studies.

This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.



Qualifications/Experience:
  • Contribute to and/or lead the design of clinical studies in close collaboration with the Clinical Development Team
  • Monitor protocol compliance including assessment of inclusion and exclusion criteria, patient medical history, concomitant medications,  and key safety and efficacy measures
  • In collaboration with the Medical Lead, review protocol deviations to identify cause and appropriateresolution
  • In collaboration with the Medical Lead, perform regular medical review of individual subjectdata
  • Collaborate with the Clinical Development Team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate datareporting
  • Provide scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
    • In collaboration with the Clinical Development Team, contribute to database lock, statistical analysis plans, and preparation of Clinical Study Reports and other clinical documents.
    • Complete and/or lead other specialprojects
    • Review and summarize relevantliterature
    • Contribute to drafting manuscripts and other publications andpresentations
    • Provide support for advisory boards, consultant meetings, and investigator meetings, including preparation and/or delivery ofpresentations
    • Understand the competitive landscape and provide insights on strategic development pathways
    • Keeps abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatoryrequirements
    • As appropriate, coach and guide less experienced ClinicalScientists
    • Proactively seek out and recommend processimprovements

 

  • Minimum of 5years clinical development experience in the pharmaceutical/biotech industry (clinical science, clinical operations, medical writing,etc.)
  • BS/MS/PhD in a related life sciencediscipline
  • Comprehensive understanding of the drug development process from Phase 1 to Phase3
  • Prior oncology drug development experiencepreferred
  • Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
  • Experience with interacting with medical monitors, development operations (clinical operations, data management , program management, regulatory affairs, medical writing) and clinicalinvestigators
  • Patient profile and data listing reviewexperience
  • Up to date in new clinical trial designs inoncology
  • Stronq analytical, problem-solvinq , and scientific writinqskills
  • Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, and analyticalskills
  • High level of organizational and project managementskills
  • Demonstrated ability to work independently in a matrixenvironment
  • Demonstrated ability to prioritize and manage multiple taskssimultaneously
  • Demonstrated ability to influence throughcollaboration
  • Flexibility to accommodate changes in priorities and projectneeds

 



Location: Cambridge, MA

Contact: talentacquisition@bostonbiomedical.com

Post Date: 11/19/2019 11:15:45 AM
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