Medical Monitor - Usona Institute

JOB OBJECTIVE: Reporting to the Chief Medical Officer or Senior Executive, the Medical Monitor is responsible for the ongoing medical oversight and safety monitoring of Usona-sponsored clinical trials. This role ensures subject safety, supports trial integrity, and provides real-time medical and scientific input during the execution of clinical trials. The Medical Monitor will serve as the primary medical liaison for internal stakeholders, CRO partners regarding trial-related medical issues. This position plays a pivotal role in providing medical oversight and in ensuring data quality to support successful study execution.

CORE DUTIES:

Safety Oversight:

1. Provide comprehensive daily medical oversight for clinical trials, including but not limited to eligibility assessments, detailed adverse event (AE) and serious adverse event (SAE) reviews, and clinical interpretation of safety-related data (e.g., labs, ECGs, vital signs, questionnaires).

2. Conduct and document safety signal detection activities in collaboration with the pharmacovigilance (PV) team to monitor and respond to trends or emergent risks.

3. Coordinate with CRO medical monitors to align site-level medical decisions with study protocol, promoting uniformity in clinical evaluations and data interpretation.

4. Ensure that all safety oversight activities are accurately and promptly documented, reviewed, and integrated into internal safety logs and regulatory outputs.
Clinical Trial Support:

5. Monitor and assess clinical protocol deviations, providing timely medical input on subject eligibility, discontinuation, and compliance.

6. Evaluate investigator-reported outcomes in real time and participate in case-by-case discussions that inform study continuation or discontinuation decisions.

7. Support internal quality reviews for medical decision consistency, reviewing case narratives and investigator commentary to inform trial progression.

Data Review and Interpretation:

8. Collaborate closely with clinical data management and statistical teams to ensure all medical listings (including AEs, concomitant medications, medical history) are reviewed for completeness, accuracy, and potential safety issues.

9. Review adverse event, medical history, and concomitant medication coding to ensure coding is accurate and informative.

10. Support interpretation of cumulative safety data and interim analyses, identifying trends or inconsistencies that require escalation or clarification.

11. Contribute feedback to weekly internal safety data reviews and summarize key findings for leadership or DSMB discussions.
Regulatory and Compliance Support:

12. Conduct and document final causality and expectedness determinations for all SAEs/SUSARs submitted to regulatory agencies.

13. Partner with Regulatory Affairs and PV to draft or review Development Safety Update Report (DSUR) safety sections and Investigator Brochure updates.

14. Maintain a current understanding of FDA reporting expectations and international safety monitoring requirements to ensure alignment with Usona's obligations.

Cross-Functional Collaboration:

15. Engage regularly with Clinical Operations, Regulatory Affairs, Data Management, and Pharmacovigilance to facilitate seamless study conduct and problem resolution.

16. Actively participate in safety review meetings, backlog resolution task forces, and cross-functional planning sessions.

17. Provide clinical insights into issues such as patient risk management, protocol amendments, and data reconciliation strategy.

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

19. Embraces Emotional & Social Intelligence (ESI) core principles and implements them in daily work.

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

KEY QUALIFICATIONS:

1. Medical Degree (MD or DO) with a strong foundation in psychiatry, neurology, or a clinically relevant specialty.

2. Minimum 3-5 years of direct experience in medical monitoring, clinical safety assessment, or pharmacovigilance within the life sciences industry.

3. Deep understanding of clinical trial conduct, ICH GCP principles, and safety regulations including FDA 21 CFR Part 312.

4. High proficiency in MedDRA coding practices.

5. Demonstrated ability to interpret complex safety data, apply medical judgment, and formulate clear regulatory conclusions.

6. Excellent interpersonal, analytical, and communication skills, with a collaborative mindset.

PREFERRED QUALIFICATIONS:

1. Direct experience supporting Phase 2 or Phase 3 clinical trials, ideally in central nervous system or psychiatric drug development.

2. Familiarity with the regulatory and operational nuances of psychedelic compound research.

3. Prior involvement in SAE causality assessments and data integrity oversight.

PHYSICAL DEMANDS:

1. Ability to remain stationary for extended periods during review and documentation tasks.

2. Minimal travel expected; occasional attendance in investigator or internal milestone meetings may be required.

At Usona, we are committed to building a diverse workforce that reflects the communities we serve and creating a culture where everyone belongs. As an Equal Opportunity Employer, we welcome and encourage applications from all backgrounds, ensuring that employment decisions are made fairly and equitably.