Clinical Research Scientist, Pharmacology
Aveo Oncology - Cambridge, MA

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As part of a team working on AVEO global oncology clinical trials, the person will focus on Clinical Pharmacology studies within the Clinical organization.


Responsibilities include but are not limited to the following:
  • Assisting with developing study protocols, Informed Consents and Investigator Brochures.
  • Assisting in the preparation of documents for Regulatory activities and submissions.
  • Participating in the identification, selection and qualification of clinical investigative sites, as required.
  • Biobank Sample Tracking and management of Biorepository vendor
  • Partner with Clinical Operations, Biostatistics, Medical, Regulatory, Preclinical and Legal staff assigned to program to ensure execution is consistent with intent.
  • Participate in the preparation of clinical study reports and annual reports.
  • Participate in CRF development and study data reviews
  • Identifying outsourcing vendors, setting up meetings, presentations and request proposals (RFPs);
  • Working with Clinical Operations on the scope of responsibilities with outsourcing vendors;
  • Work closely with the preclinical and clinical teams on the logistics of incorporating specific biomarker and other project specific laboratory assays into protocols.
  • Assisting in the management of external vendors and CROs that are associated with pharmacokinetics, pharmacogenomic and biomarker data
  • Tracking of samples and sample analysis throughout the various stages of the study;
  • Assisting with preparation and presentation at investigator meetings and/or sites as required;
  • Developing study/clinical site specific guidelines and tools as necessary;
  • Presentation at internal meetings as necessary
  • Participating in Investigator Meetings and Advisory Boards as necessary;
  • Assist in preparation of abstracts, manuscripts, posters and slide sets for publication.
  • Assist in analysis of data as required.

  • BS/BA degree in life sciences
  • 5+ yrs of industry clinical research experience (biotech/ pharma/ CRO);
  • Experience with writing study protocols
  • Experience and interest in Clinical Pharmacology a plus
  • Understanding of ICH, GCP and relevant regulatory requirements is highly desirable;
  • Vendor management experience a plus
  • Strong attention to detail;
  • Solid time management skills;
  • Ability to multi-task, work independently, and travel up to 15% of time;
  • Excellent verbal and written communication skills;
  • Strong inter-personal skills;
  • Excellent computer skills, specifically hands-on experience with Word, Power Point and Excel.

Aveo Oncology - 17 months ago - save job - block
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