JOB OBJECTIVE: The Director of Clinical Operations will be responsible for overseeing the planning, execution, and management of psychedelic clinical trials conducted as part of Usona's drug development programs. This leadership role, reporting to the Chief Medical Officer, requires a seasoned professional who can provide strategic direction, ensure regulatory compliance, and drive operational excellence and development within the Clinical Operations team.
CORE DUTIES:
- 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.
- Understand and comply 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.
- Conduct performance evaluations and support 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.
- Demonstrate inclusion through their own words and actions and be accountable for a safe workspace. Act with kindness, curiosity, and respect for others.
- Embrace and be open to incorporating Emotional & Social Intelligence (ESI) core principles in daily work.
- Understand and comply with ethical, legal, and regulatory requirements applicable to our business.