Director, Clinical Operations
Our client is a biotechnology company focused on developing biologic therapies. 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 III 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+ 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 III 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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