Director of Clinical Operations – Neuroscience

Position: Director of Clinical Operations

Reports To: Chief Medical Officer

Position Overview: The Director of Clinical Operations will oversee the planning, execution, and management of psychedelic clinical trials. Reporting directly to the Chief Medical Officer, this role requires a highly experienced professional with a proven track record in clinical operations, strategic oversight, and regulatory compliance. The successful candidate will be key in shaping and advancing the company’s drug development programs while ensuring operational excellence and clinical success.

Responsibilities

Strategic Leadership:

• Develop and implement clinical operations strategies aligned with company goals.
• Provide leadership and direction to the Clinical Operations team.
• Collaborate with cross-functional teams to ensure the successful execution of clinical trials.

Operational Management:

• Oversee the planning, initiation, and execution of clinical trials.
• Ensure trials are conducted in compliance with all FDA regulatory requirements, Good Clinical Practice (GCP) guidelines, and organizational SOPs.
• Manage clinical trial budgets, timelines, and resources to ensure efficiency and cost-effectiveness.
• Proactively identify risks and lead team members to mitigate risks in a timely fashion.
• Understands and complies with ethical, legal, and regulatory requirements applicable to our business.

Team Development:

• Mentor and develop Clinical Operations staff, fostering a collaborative and high-performance culture.
• Conducted performance evaluations and supported career development for team members.

Embrace and Utilize AI Tools:

• Demonstrate a genuine curiosity and enthusiasm for leveraging AI technologies to enhance efficiency, improve processes, and drive innovation within your role. Willingness to learn and adapt to new AI tools is essential.

Vendor Management:

• Select and manage relationships with external vendors, including CROs, labs, and other service providers.
• Negotiate contracts and ensure vendors meet project deliverables and quality standards.

Stakeholder Engagement:

• Serve as the primary point of contact for internal and external stakeholders on clinical operations matters.
• Prepare and present regular updates to senior management on the status of clinical trials.

Requirements

• Bachelor’s degree or higher in a relevant scientific discipline.
• At least 10 years of relevant experience in clinical operations, including previous experience working in a pharmaceutical company.
• Experience with site monitoring.
• Experience with CNS trials.
• Experience with psychedelic trials Preferred.
• Experience with global regulatory submissions (e.g., EMA)
• Experience managing a team of clinical operations staff.
• Proficiency in resource planning and financial management (clinical trial budgeting).
• Deep working knowledge of GCP, ICH guidelines, and FDA regulations.
• Well-organized and detail-oriented, with strong written and verbal communication skills.
• Skilled in collaborating with internal and external cross-functional teams, vendors, and scientific and clinical advisors.
• Effective process and project management skills.
• Ability to travel 25% of the time.

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