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Clinical Jobs USA | Program Manager @ Calithera Biosciences - B.S degree in a scientific field or equivalent and 7+ years of clinical experience............

Clinical Jobs USA | Program Manager @ Calithera Biosciences

Clinical Jobs USA | Program Manager @ Calithera Biosciences: Calithera Biosciences is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer.Our lead product candidate in tumor metabolism, CB-839, is an internally discovered, first-in-class inhibitor of glutaminase, a critical enzyme in tumor metabolism. We are currently evaluating CB-839 in three Phase 1 clinical trials in solid and hematological tumors.In tumor immunology, our lead preclinical program is directed at developing inhibitors of the enzyme arginase and may provide a first-in-class therapeutic agent for this novel target. Our ongoing research efforts are focused on discovering additional product candidates against novel tumor metabolism and immunology targets.

Clinical Jobs USA | Program Manager @ Calithera Biosciences

Primary Responsibilities

  • Contributes significantly to clinical study documentation including clinical protocols, statistical analysis plan, clinical narratives and clinical study report.
  • Participates in the selection of vendors and Investigators; proactively manages Vendors and sites.
  • Actively monitors the study through remote data review, assessing trends which facilitate the quality management of the study.
  • Manages study timelines, budget, and resource allocation.
  • Proactively identifies project risks and manages issues to resolution.
  • Maintains effective relationships with clinical collaborators and clinical site personnel.
  • Analyzes information, and utilizes prior clinical experience and problem solving skills to ensure the best possible outcome for the clinical research program.
  • Proactively participates in all aspects of financial management of the trial(s): budget setting, tracking payments and forecasting.
  • May mentor, manage and/or train more junior staff.
  • Prepare clinical research publications for appropriate medical and scientific conferences.
  • Position may include up to 30% domestic and/or international travel.

Requirements:

  • Bachelor’s degree in a scientific field or equivalent and 7+ years of relevant clinical experience.
  • 5+ years direct experience managing clinical studies, preferably including field monitoring experience.
  • Candidates must be experienced with a proven track record in a clinical research management, high-energy, able to function in a growing, dynamic environment and able to multi-task and communicate at all levels within the organization.
  • Sound computer skills: proficient in the use of Excel and Word and experienced in the use of EDC systems.
  • Strong understanding and experience with clinical trial budget development and management.
  • Ability to work with a high degree of initiative and independence while exercising appropriate judgement when direction is required.
  • Thorough knowledge of ICH/GCP guidelines, FDA requirements, and drug approval process.
  • An understanding of Quality Management and the Quality Cycle as it pertains to the clinical trial domain
  • Ability to trouble-shoot, conduct root cause analysis and develop plans for corrective and preventative action.
  • Excellent analytical, negotiation, and problem-solving skills.
  • Outstanding organizational, communication, and presentation skills.

Clinical Jobs USA | Program Manager @ Calithera Biosciences

Apply Now: hr@calithera.com

View Original Notification : http://www.calithera.com/about-us/careers/

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