About the opportunity Our client, a clinical stage biotech, is seeking an experienced physician to serve as Medical Monitor on its early clinical programs. This fractional role supports first in human Phase 1 studies in healthy volunteers and cardiometabolic indications. You will be the medical voice of the study team, safeguarding participant safety and guiding key clinical decisions through dose escalation. The role is fully remote, with the flexibility to join leadership in San Diego on occasion. Key responsibilities Serve as the study Medical Monitor for first in human Phase 1 trials, including single ascending dose (SAD) and multiple ascending dose (MAD) cohorts Provide real time medical review of safety data, including adverse events, laboratory results, vital signs and ECGs Partner with investigators and Phase 1 units on eligibility, protocol questions and participant safety Contribute to dose escalation decisions and participate in Safety Review Committee meetings Review and assess serious adverse events in collaboration with drug safety and pharmacovigilance Provide medical input on protocols, investigator brochures, informed consent forms and clinical study reports Collaborate closely with clinical operations, clinical pharmacology and biostatistics on study conduct and data interpretation Present study updates and medical insights to senior leadership as needed

Qualifications

Required MD or DO; board certification in internal medicine, cardiology, endocrinology or a related specialty preferred Hands on medical monitoring experience on first in human Phase 1 studies Experience with healthy volunteer studies and SAD/MAD dose escalation designs Strong working knowledge of ICH GCP and FDA regulations for early phase trials Ability to work independently in a fractional, remote consulting capacity Preferred Therapeutic experience in cardiometabolic areas such as obesity, diabetes, dyslipidemia, MASH or cardiovascular disease Background at a Phase 1 unit, CRO early phase group, or early development team at a biotech or pharma company Experience supporting IND submissions and Safety Review Committees Comfort presenting to executive leadership