Director, Clinical Operations - Usona Institute - Promega

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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity, and respect for others.

8. Embracing and being open to incorporating Emotional & Social Intelligence (ESI) core principles in daily work.

9. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. Bachelor’s degree or higher in a relevant scientific discipline.

2. At least 10 years of relevant experience in clinical operations, including previous experience working in a pharmaceutical company.

3. Experience managing a team of clinical operations staff.

4. Proficiency in resource planning and financial management (clinical trial budgeting).

5. Deep working knowledge of GCP, ICH guidelines, and FDA regulations.

6. Well organized and detail oriented, with strong written and verbal communication skills.

7. Skilled in collaborating with internal and external cross-functional teams, vendors, and scientific and clinical advisors.

8. Effective process and project management skills.

9. Ability to travel 25% of the time.

PREFERRED QUALIFICATIONS:

1. Experience with site monitoring.

2. Experience with CNS trials.

3. Experience with psychedelic trials.

4. Experience with global regulatory submissions (e.g., EMA).

5. Experience using generative artificial intelligence (e.g., ChatGPT) in work activities.

PHYSICAL DEMANDS:

1. Ability to use a computer/Microsoft Office applications.

At Usona, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.