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Senior Clinical Trial Manager

Employer
Kezar Life Sciences
Location
South San Francisco, California
Start date
Nov 26, 2022

View more

Discipline
Clinical, Clinical Research, Clinical Trials
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Senior Clinical Trial Manager. This position will independently lead the planning, execution, and reporting of multiple Phase 1b and/or Phase 2 trials. This is an exciting opportunity to play a strategic role in the research and development of novel therapies for serious diseases.

Kezar is developing first-in-class small molecules to treat serious immune-mediated diseases and cancer. KZR-616, Kezar’s lead clinical asset, is a selective inhibitor of the immunoproteasome and is currently being evaluated in multiple clinical trials. KZR-261, Kezar’s first oncology asset, is an inhibitor of protein secretion pathway via the Sec61 translocon and is currently being evaluated in a large Phase 1 trial.


RESPONSIBILITIES

  • Lead cross-functional teams through activities dedicated to study design and clinical trial execution
  • Contribute to clinical study documentation including clinical protocols, investigator brochures, informed consents, case report forms, various study plans, and clinical study reports
  • Ensure data quality by performing listing reviews per established plans/processes
  • Participate in the selection and oversight of vendors and Investigators
  • Manage study timelines and budget; proactively participate in budget setting, forecasting, and other aspects of financial management of the trial (vendor accruals and site payments)
  • Proactively identify project risks and manage issues through resolution
  • Cultivate and maintain effective relationships with CRO, other clinical vendors, and clinical site personnel
  • Analyze information, and utilize prior clinical experience and problem-solving skills to ensure the best possible outcome for the clinical research program
  • Support SOP and process development and improvement

REQUIREMENTS

  • Bachelor’s Degree in a relevant scientific field or related discipline
  • Minimum of 6 years of Clinical Research experience in the pharmaceutical and/or biotechnology industry (including 3+ years of direct experience managing oncology clinical studies)
  • Sound computer skills: proficient in the use of Excel, Word, Project, and PowerPoint; experienced with EDC and IRT systems
  • Ability to work with a high degree of initiative and independence while exercising appropriate judgment when required
  • Strong multi-tasking skills and ability to balance multiple deadlines and competing priorities
  • Strong organizational, communication (oral and written), and interpersonal skills
  • Experience monitoring clinical trials, a plus
  • Thorough knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs
  • Ability to travel up to 20% domestic and/or international

Kezar Life Sciences is an Equal Opportunity Employer

Company

Company info
Website
Phone
650-822-5600
Location
4000 Shoreline Ct
Suite 300
South San Francisco
94080
United States

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