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
- Website
- http://www.kezarlifesciences.com/
- Phone
- 650-822-5600
- Location
-
4000 Shoreline Ct
Suite 300
South San Francisco
94080
United States
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