Phase I Site Operations Director

Phase 1 Site Operations Director

Seeking a phase 1 clinical research professional with medical and/or operational clinical research site background, must have Phase 1 unit experience. Will work under senior leadership CEO and COO to design, build, and lead a specialized clinical trial unit for early-phase AD studies. This role involves the strategic and operational management of complex clinical trials, identifying key staffing positions needed and hiring quality individuals, medical and safety oversight, targeted recruitment, and regulatory expertise to create, operate and oversee a functional phase 1 unit, from the ground up. The goal is to create a compliant, safe, and efficient environment complete with facilities, participants and multidisciplinary staff for conducting "first-in-human" clinical trials, where new drugs are tested for safety and dosing in a small group of volunteers.

Key responsibilities:

1. Cooperative strategic leadership and planning

• Develop the program strategy: Work with institutional and executive leadership to define the vision for the early-phase clinical trial unit.
• Build the unit infrastructure: Manage the creation of the facility, which must have ICU-level readiness for intensive 24/7 monitoring and emergency response protocols.
• Strategic planning: Define the unit's short-term and long-term goals and develop a strategic business plan to ensure continued growth and success.

2. Operational management

• Oversee trial delivery: Direct studies, ensuring they are executed on time, within budget, and to the highest quality standards.
• Manage complex logistics: Drive and optimize the unit's operational processes, from protocol execution and regulatory submissions to patient recruitment and data collection.
• Track Metrics

3. Team and talent management

• Assemble and lead the team: work along side executive leadership to recruit, hire, and mentor a small team of specialized Phase 1 Unit staff.
• Ensure staff training: ensure all personnel are trained and compliant with the SOPs, phase 1 unit operations, clinical trial protocols and regulatory requirements.
• Foster collaboration: Facilitate effective communication and teamwork.

4. Regulatory and quality oversight

• Ensure compliance: Guarantee that all trials adhere to stringent ethical and regulatory standards, including Good Clinical Practice (GCP) guidelines and FDA regulations.
• Collaborate on audits: work alongside operational leadership and QA/QC Department to maintain audit readiness standards and prepare for any sponsor or FDA audit.
• Risk Management: Proactively identify, report and collaboratively mitigate risks that could jeopardize study timelines, budgets, or patient safety.

Essential qualifications and experience

• Experience: experience in early-phase clinical trial management, including experience in a phase 1 unit.
• Education: Any advanced degree
• Technical skills: Deep knowledge of ICH-GCP guidelines, FDA regulations, and the drug development process.
• Leadership skills: Excellent project management, problem-solving, and communication skills are essential for leading multi-functional teams.