Director of Clinical Affairs Job at Discover International, Irvine, CA

Y0dXWGNNUFVkMjFCWjBjNWVNUUplL3JiRXc9PQ==
  • Discover International
  • Irvine, CA

Job Description

Responsibilities

  • Design and provide oversight of clinical research programs for IVD products.
  • Build and maintain strong relationships with key opinion leaders (KOLs) and integrate their feedback into study protocols and development strategy.
  • Ensure clinical study design aligns with both scientific objectives and commercial goals.
  • Lead planning and execution of clinical trials (Phases I–IV), ensuring adherence to GCP guidelines and all relevant regulatory requirements.
  • Manage clinical budgets, project timelines, resources, and cross-functional coordination to ensure successful trial outcomes.
  • Establish conditions for evaluating safety, efficacy, medical utility, and market potential of product candidates.
  • Analyze and interpret clinical trial results in preparation for regulatory submissions (e.g., FDA, CE-IVDR).
  • Serve as the clinical safety expert for one or more clinical development programs.

Qualifications

  • Bachelor’s degree in a scientific, medical, or technical discipline.
  • Minimum 7 years of experience in clinical research, clinical affairs, or related field within a regulated industry.
  • Direct experience in the in vitro diagnostics (IVD) industry.
  • Demonstrated ability to manage clinical trials from design through regulatory submission.
  • Strong working knowledge of GCP, FDA, and international clinical trial standards.

Job Tags

Similar Jobs

The Peter G. Peterson Foundation

Research Associate Job at The Peter G. Peterson Foundation

 ...to a variety of external partners. In recent months, the team has worked with leading policy analysts from think tanks across the political spectrum to develop analyses of major policy issues, published analyses of major budget proposals before Congress, and prepared primers... 

In-Finite Search Solutions

Medical Malpractice Attorney Job at In-Finite Search Solutions

 ...Medical Malpractice Attorney &##128205; Cleveland, OH | &##128188; Full-Time | &##128176; $120,000$190,000/year A growing personal...  ...~ Ohio Bar license in good standing ~ Excellent negotiation, writing, and research skills ~ Strong attention to detail and ability... 

Insight Global

Analytical Chemist Job at Insight Global

Day to Day: Insight Global is looking for an Analytical Chemist to join the R&D organization of a large Medical Device company. The Chemist will be responsible for hands on laboratory activities including executing analytical tests and techniques. On a daily basis, they...

Sentinel Group

Salesforce Business Analyst Job at Sentinel Group

 ...for our Wakefield, MA office. The Purpose of Your Role: Are you passionate about leveraging Salesforce to drive business success? As a Salesforce Business Analyst at Sentinel, you will serve as the primary Salesforce expert for the entire organization while focusing... 

ECLARO

Bioprocess Associate - Night Shift (6pm - 6am) Job at ECLARO

 ...JOB TITLE: Bioprocess Associate Night Shift (6pm 6am) Location: East Syracuse, NY (100% ONSITE) Duration: 6 months initial (potential...  ..., or clean room operations Prior manufacturing experience Prior experience with cGMP operations or aseptic technique...