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.

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.