Director of Clinical Operations

  • Location
    San Diego, California
  • Job type
    Direct Hire
  • Salary
    $ 180000 - $ 200000 / Hour
  • Category
    Medical & Science - Pharmaceutical - Clinical

Our client is a global immuno-oncology biopharmaceutical company and is seeking a Director of Clinical Operations. In this role, you will report to the Global Head of R&D and would be responsible for oversight for clinical study conduct including leading internal and external sub-teams, study planning, financial oversight, partner management, monitoring study and program timelines, and ensuring compliance with GCP.

This is a full time permanent role on-site in San Diego, CA. Please apply today for more information!

Qualifications:

Minimum BS Degree, Advanced degree preferred
10 years of clinical trial experience with at least 5 years of experience in the pharmaceutical/biotech industry
Experienced in managing clinical trial site/vendor relationships and resource management
Direct experience with overseeing audits/inspections, leading multi‐functional teams and maintaining timelines
Demonstrates strong problem‐solving and leadership skill-sets
Strong Project Leadership skills including a collaborative and team-oriented approach
International experience is a plus
Able to work on-site in San Diego, CA

Responsibilities:

Actively participates in developing and drafting protocols, amendments, CRF, informed consent forms, Investigator Brochures, annual progress reports, clinical study reports and other documents as needed or requested. May also review required clinical documents, if developed by vendors/partners
Responsible for the development of, and the oversight for, clinical study milestones to support program objectives
Oversees and guides clinical operations staff responsible for the implementation and execution of international clinical studies
Ensures that clinical studies are properly resourced, managed, and executed following the study plan and in accordance with established timelines and quality standards
Provides high level oversight of clinical study data, i.e., flow from the sites (CRF completion) to data entry (data entered into database) to data listings/tables/figures
Ensures that clinical studies follow guidelines and necessary processes and procedures, as applicable (e.g., Code of Federal Regulations, ICH Guidelines and Good Clinical Practices, FDA, EMA, PMDA) and appropriate industry standards


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Reference number US_EN_2_108175_328484