The Medical Monitor provides physician-level medical oversight for early-phase clinical trials conducted at our Clinical Pharmacology Units. This role is responsible for safeguarding participant safety throughout study conduct, including screening/eligibility review, real-time clinical decision-making during dosing and confinement periods, adverse event (AE) and serious adverse event (SAE) assessment, and dose-escalation safety review in collaboration with Sponsors and Safety Review Committees (SRCs). The Medical Monitor serves as the primary point of medical contact for principal investigators, study staff, and sponsors regarding participant safety and eligibility decisions.

Participant Safety & Clinical Oversight

• Provide on-call medical coverage during screening, check-in, dosing, and confinement periods for Phase I studies, including FIH and healthy volunteer trials.
• Review and approve subject eligibility based on medical history, physical examination, laboratory results, ECGs, and protocol-specified inclusion/exclusion criteria.
• Respond promptly to medical emergencies and adverse events during study conduct; direct emergency management and escalation to higher levels of care when necessary.

Dose Escalation & Safety Review

• Participate in Safety Review Committee (SRC) meetings and provide medical input on dose-escalation decisions for FIH and multiple ascending dose (MAD)/single ascending dose (SAD) studies.
• Review real-time safety data (vital signs, labs, ECGs, PK data where applicable) to inform stopping rules and dose-escalation criteria.
• Communicate safety findings and recommendations to Sponsors, the Principal Investigator (PI), and the Institutional Review Board (IRB)/Ethics Committee as required.

Protocol & Regulatory Support

• Review study protocols, informed consent forms, and safety monitoring plans for medical and scientific accuracy prior to study initiation.
• Ensure medical procedures comply with Good Clinical Practice (GCP), ICH guidelines, FDA regulations (21 CFR), and applicable local/national regulations.
• Support development of medical monitoring plans and safety narratives.
• Serve as medical liaison during sponsor audits and regulatory inspections.

Cross-Functional Collaboration

• Collaborate with the Principal Investigator, Sub-Investigators, Clinical Research Coordinators, nursing staff, and Pharmacovigilance/Safety teams.
• Provide medical training and guidance to clinical staff on protocol-specific safety procedures.
• Participate in investigator meetings, sponsor teleconferences, and internal safety review discussions.

• M.D. or D.O. degree from an accredited medical school, with an active, unrestricted medical license.
• Minimum 5 years of clinical experience in a medical setting.
• Minimum 2 years of experience in clinical research, clinical pharmacology, biotechnology, or CRO industry.
• Working knowledge of ICH-GCP guidelines, FDA regulations, and human subjects protection requirements.
• Strong understanding of pharmacokinetics/pharmacodynamics (PK/PD) principles as they relate to dose-escalation safety decisions.
• Excellent written and verbal communication skills, with the ability to produce clear safety narratives and communicate effectively with sponsors, regulatory bodies, and multidisciplinary teams.
• Proven ability to make timely and sound medical decisions based on complex clinical data.
• Detail-oriented approach with the ability to multitask and manage priorities in a fast-paced environment
• Strong leadership qualities with the ability to mentor and guide junior staff members.

• Prior experience serving as a Medical Monitor, Principal Investigator, or Sub-Investigator on Phase I/First-in-Human studies.
• Experience presenting at or participating in Data Safety Monitoring Boards (DSMBs) or Safety Review Committees.

• Primarily remote; however, in-person training will be required. Occasional travel may also be required