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:

• Postgraduate degree in life sciences.
• 15+ years of clinical research experience, including CRO and sponsor roles.
• Proven track record in GCP compliance and FDA regulations.
• Experience in managing clinical studies and CROs.
• Strong leadership, strategic thinking, and problem-solving skills.
• Excellent communication and team-building abilities.
• Willingness to travel domestically and internationally as needed.

Competencies:

• Flexibility and multitasking in a dynamic environment.
• Strong knowledge of ICH-GCP guidelines.
• Hands-on approach to operational tasks.
• Excellent presentation, documentation, and interpersonal skills.
• High emotional intelligence and ability to build trust.
• Strong business acumen and analytical skills.

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.