We are searching for a Director of Clinical Operations for a clinical stage biotech company developing therapies for autoimmune disease, including Crohn’s Disease. The Director of Clinical Operations will drive all clinical development strategy, ensuring compliance with all regulatory agency requirements.
Requirements for the Director of Clinical Operations:
- Bachelor’s degree, RN or BSN or equivalent
- 10+ years’ experience in study management
- Experience in conducting international studies preferred
- A track record of accomplishment in managing multiple competing priorities
- Thorough knowledge and adherence to GCPs
- Strong attention to detail
- Excellent communications skills, oral, written and electronic
- Strong leadership skills with the ability to work collaboratively at all levels within a science driven environment
- The ability to travel up to 25% as needed.
Responsibilities of the Director of Clinical Operations:
- Implement clinical development plans.
- Work with other departments and functions to implement clinical trial protocols.
- Participate and assist in design and preparation of protocols and case report forms.
- Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
- Evaluate potential clinical CROs and sites according to established criteria of acceptability.
- Responsible for budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
- Supervise and oversee contract research organizations, clinical vendors, and consultants
- Supervise and manage activities of clinical operations personnel.
- Prepare clinical documents for regulatory submissions.
Occupational Category: 19-1040 Medical Scientists
: Please apply using the form or send your resume to Debbie Winkelbauer