Social network you want to login/join with:
ARTO is currently partnered with a early stage, European biotechnology company specialising in Ophthalmic diseases using innovative Gene Therapies. With upcoming Phase I clinical trials, they are searching for an experienced Clinical Operations leader to drive these first in human studies.
As Head of Clinical Operations, you’ll be responsible for overseeing the planning, execution, and delivery of our clinical trials. You’ll work closely with cross-functional teams and senior leadership to ensure our programs are designed and run efficiently and also meet regulatory requirements. This is a key leadership role.
Key Responsibilities
* Lead the development and execution of clinical operations strategy across all programs.
* Oversee all aspects of clinical trial management, including site selection, vendor oversight, patient recruitment, monitoring, and study close-out.
* Build and manage a high-performing Clinical Operations team
* Partner with Clinical Development, Regulatory and Quality to ensure alignment on trial design and execution
* Ensure trials are conducted in compliance with GCP, regulatory requirements, and company SOPs.
* Cultivate strong relationships with investigators, CROs, and other external partners.
* Serve as a key point of contact during regulatory inspections and audits.
Qualifications
* 10+ years of clinical operations experience in biotech or pharma, with at least 5 years in a leadership role.
* Proven track record of successfully leading Phase I and II clinical trials.
* Deep understanding of ICH-GCP, FDA regulations, and international clinical research guidelines.
* Strong leadership skills with the ability to build, mentor, and inspire a growing team.
* Excellent project management, organizational, and communication skills.
* Comfortable operating in a fast-paced, dynamic environment with evolving priorities.
#J-18808-Ljbffr