What are the responsibilities and job description for the Director of Clinical Operations position at Workforce Genetics?
Job Description
Job Description
Our client is a clinical-stage biotech dedicated to advancing therapies for multi-drug resistant infections. Our mission is to tackle today's most challenging infections and those on the horizon.
Role Overview : The Director of Clinical Operations will lead the design and implementation of clinical trials, focusing on combating bacterial infections, particularly multi-drug resistant pathogens. This role demands active leadership, strategic planning, and hands-on management to ensure trials are conducted efficiently within timelines and budgets, maintaining the highest quality standards.
Location : Remote on the east coast of the US
Key Responsibilities :
- Oversee clinical trial planning and execution.
- Lead and manage clinical operations staff and external consultants.
- Coordinate regulatory document submissions (NDAs, INDs, annual reports).
- Manage CROs to ensure high-quality, timely, and budget-compliant studies.
- Collaborate with cross-functional teams for trial material delivery.
- Ensure compliance with FDA and international regulatory standards.
- Develop and maintain SOPs and internal systems for clinical study compliance.
- Conduct quality management, including CAPAs and risk management.
- Support Pharmacovigilance activities and safety reviews.
- Provide senior-level briefings and updates to management.
Requirements :
Competencies :
Join Us : Be part of a team dedicated to making a tangible impact on patient outcomes. Apply now and contribute to our mission of combating multi-drug resistant infections.
