Director, Clinical Affairs - Minimally Invasive Surgery Market
Hayward, CAAll locationsHayward, CASan Francisco, CA Hybrid
$190,000–$250,000 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
The Director of Clinical Affairs - Minimally Invasive Surgery Market (e.g., Thyroid) is responsible for the successful planning, directing and execution of the minimally invasive surgery market portfolio. The position requires maintenance of up-to-date knowledge of all applicable US, international regulation and regulatory guidance for the conduct of clinical trials in compliance with all sponsored protocols, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), as well as in-depth product and clinical knowledge of indications. She/he brings strong leadership, problem-solving, and decision-making abilities.
What you'll bring
- 10+ years of progressive industry experience with a medical device company.
- 5+ years clinical trial management experience with class II and class III medical devices.
- Experience in conducting multi-center IDE clinical trials or pivotal clinical studies intended to support FDA approvals
- Strong hands-on experience in directing and managing CROs, Core Labs, and Safety Committees (e.g., DSMB and CEC).
- Demonstrate ability to function as both a project leader and a project team member.
- Proficient knowledge in devices that support ultrasound guided soft tissue ablation.
- Demonstrate expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations.
- Demonstrate expert knowledge and comprehensive understanding of US and European current practice guidelines on percutaneous soft tissue ablation for the treatment of benign and cancerous nodules
- Knowledge of electronic data capture systems and web-based clinical trial management tools.
- Meticulous attention to detail.
- Ability to analyze and interpret clinical data quickly and accurately.
- Excellent interpersonal, written, verbal communication & organizational skills.