Director, Clinical Operations

JOB OBJECTIVE: We are seeking a driven Director of Clinical Operations who will assist in the strategic study design, planning, and oversight of clinical trials, ensuring alignment with organizational goals and objectives. As the Director of Clinical Operations, you will oversee multiple aspects of clinical operations to ensure the highest standards of clinical study execution. You will collaborate with cross-functional and external stakeholders and oversee all aspects of clinical trial execution and department initiatives. The Director of Clinical Operations will report to the Chief Medical Officer.

CORE DUTIES:

1. Drive the development of comprehensive strategies to optimize clinical trial design, data collection, analysis, and inspection readiness for successful regulatory submissions. Stay abreast of evolving clinical operations regulatory guidelines and requirements, proactively identifying potential challenges or opportunities and recommending appropriate actions to ensure compliance and expedited approvals.

2. Oversee the implementation and conduct of Usona-sponsored clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP)/ICH guidelines, FDA regulations, and department Standard Operating Procedures (SOPs). Ensure excellent study execution from various perspectives, including patient safety, data integrity, quality, compliance, budget, and timeline adherence.

3. Collaborate with cross-functional teams to provide expert clinical operational insights for the preparation and review of regulatory documents, such as Investigational New Drug (IND) applications, meeting briefing packages, New Drug Application (NDA) submissions, and other regulatory filings.

4. Collaborate with cross-functional stakeholders, both internal and external, to facilitate seamless communication, coordination, and collaboration. Serve as an escalation resource for internal staff (including consultants), Contract Research Organizations (CROs), and other ancillary vendors.

5. Oversee clinical trial vendor selection and provide oversight of CROs, consultants, and other ancillary vendors. Ensure effective working relationships, oversee vendor performance, and resolve any issues or concerns.

6. Develop and execute strategic initiatives, including the formulation of comprehensive plans, oversight of budgets, allocation of resources, and achievement of key objectives. Continuously monitor progress across projects, identifying potential risks and implementing proactive measures to mitigate them promptly and effectively.

7. Identify gaps and inefficiencies in clinical operation systems, processes, and workflows, conducting thorough assessments and analyses. Propose and implement innovative solutions and improvements to enhance operational efficiency, streamline processes, and optimize resource utilization while maintaining compliance with regulatory requirements.

8. Collaborate with cross-functional teams to evaluate and select appropriate technology platforms and systems to support clinical operations, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), electronic trial master files (eTMF), and other relevant software. Ensure seamless integration and effective utilization of these systems across clinical programs.

9. Develop comprehensive resource plans for clinical programs under oversight, considering project timelines, milestones, and resource requirements. Allocate resources optimally to ensure efficient execution of clinical trials, including staffing needs, vendor management, and budget allocation.

10. Manage a team of clinical operations professionals, providing guidance, support, and mentorship. Foster a positive work environment, promote professional growth, and ensure effective collaboration within the team and the organization.

11. Prepare and manage the department budget, ensuring financial oversight and adherence to budgetary constraints. In collaboration with finance and accounting staff, monitor clinical trial expenses, identify cost-saving opportunities, and maintain financial accountability.

12. Drive initiatives to improve operational efficiency and excellence within the clinical operations function. Develop and update procedural documents, including GCP SOPs, to ensure adherence to quality standards and compliance requirements.

13. Build and maintain positive relationships with internal and external stakeholders, including donors, investigators, study teams, key opinion leaders, and clinical trial sites. Foster effective communication and collaboration to support successful study outcomes.

14. Demonstrate thorough knowledge of and coach others in the appropriate application of clinical research regulations, GCPs, and best practices in compliance with applicable Usona Institute SOPs and policies.

15. Fully support the Quality Policy by incorporating quality into all aspects of work and maintaining compliance with all quality requirements, including training.

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

17. Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.

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

KEY QUALIFICATIONS:

1. At least 5 years of direct experience as a Director of Clinical Operations or higher in a Sponsor Organization.

2. A BS/BA or higher degree in a relevant scientific discipline.

3. Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.

4. Well-organized and detail-oriented with strong written and verbal communication skills.

5. Demonstrated skills in internal and external collaboration among cross-functional teams, vendors, and scientific and clinical advisors.

6. Ability to travel up to 25% of the time.

PREFERRED QUALIFICATIONS:

1. Psychedelic clinical trial experience preferred.

2. At least 2 years of previous experience as a Director of Clinical Operations in a Psychedelic Drug Development company or in a pharmaceutical company focused on psychiatric conditions.

3. Central Nervous System (CNS) clinical trial experience preferred.

PHYSICAL DEMANDS:

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

Diversity is important at Usona. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.