Director, Clinical Operations
Our client is a biotechnology company. They have asked us to assist them in a search for a Director, Clinical Operations.
Major tasks and responsibilities include
We seek candidates with the following qualifications:
- Oversees program objectives and high quality deliverables within established timelines and budgets.
- Holds responsibility for the operational conduct of the organization’s ongoing phase 3 study.
- Drives ongoing clinical operations management activities and projects.
- Ensures clinical studies are conducted according to ICH GCP and applicable US regulations, as well as identifying risks, managing issues, and implementing corrective actions as necessary.
- Prepares study reports and updates for leadership meetings.
- Works on related clinical operations documents and publications as needed.
- A Bachelor’s Degree is required, an advanced degree with scientific or healthcare training is preferred.
- Must have 7 or more years of pharmaceutical development experience in the clinical operations area.
- A minimum of 5 years of leadership experience is required.
- Experience in the conduct of infectious disease programs is preferred.
- Must be knowledgeable of FDA regulations and other international regulatory agencies.
- Experience in the end to end conduct of Phase I-IV clinical trials is required.
- Must have experience with the conduct of on Phase 3 pivotal studies.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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