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Executive Director Clinical Operations

Location: Northeast

Oversees the operational aspects of all drugs in
clinical development.

SPECIFIC RESPONSIBILITIES:

Oversees personnel responsible for the following clinical operations activities:

Surveying and qualifying investigational sites.

Contracts with Contract Research Organizations
and clinical sites.

IRB submissions.

Availability and delivery of clinical supplies.

Clinical site monitoring.

Internal clinical SOPs.

Monitoring and auditing of CROs and investigational sites to ensure that clinical studies are executed properly, on time, and in compliance with GCPs.

Review of clinical reports.

Assists with the development/implementation of protocols.

Organizes and facilitates clinical review meetings.

Establishes planning teams for projects, incorporating staff from Regulatory Affairs, Marketing and R&D.

Oversees the schedules of the projects.

Develops and oversees budgets for each project.

Reports status of the projects to clinical senior management.

Responsible for the training, supervision,
management, and professional development of all clinical operations personnel.

QUALIFICATIONS:

Master’s or Ph.D. degree preferred.

A minimum of 15 years experience with broad clinical trial management experience in a biotechnology company required.

Previous supervisory experience is required.

Active participation in FDA submissions, preferably related to biologics, required.

Ability to commit to 25% travel.

Experience in drug research and international development of biotechnology