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

aE11TFhhQ2ZUWEVFMTg1WmZVSFY=
  • 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

Chelsea Public Schools

Health - School Nurse (BMS) (SY24-25) Job at Chelsea Public Schools

Title: Health - School Nurse (BMS) (SY24-25)About Chelsea Public Schools:The Chelsea Public Schools (CPS) is a gateway school system that welcomes and educates all students and families. In CPS, we believe all children are capable of achieving their personal best by... 

Get It - Hospitality

Travel Concierge - Remote | WFH Job at Get It - Hospitality

We are seeking a dedicated and self-motivated Independent Travel Agent to join our team in a contract, remote position. In this role, you will be responsible for helping clients with their travel arrangements, ensuring they receive exceptional customer service, and promoting... 

Hellas

Videographer and Photographer Job at Hellas

 ...of fields, tracks, and tennis courts. Hellas is the only fully integrated sports construction company, controlling all business operations to deliver its products directly to the end-user, including marketing, sales, quality control, project management, maintenance, and... 

Sullivan & Hilscher Family Law

Receptionist / Administrative Assistant Job at Sullivan & Hilscher Family Law

 ...support around office as needed Qualifications Associate's degree or equivalent experience Strong interpersonal, customer service and communication skills Ability to multitask Proficient in Microsoft Office suite Reliable transportation and punctuality... 

Gotham Enterprises Ltd

Licensed Marriage and Family Therapist (LMFT) Job at Gotham Enterprises Ltd

 ...Licensed Marriage and Family Therapist (LMFT) California Job Type: Full Time Location: Garden Grove, California Work Hours: Monday to Friday, 9 AM 5 PM Compensation: $115,000 - $120,000 per year + benefits Are you an LMFT looking to make a meaningful...