Medical Monitor, Oncology

About the role

A clinical-stage oncology biotech company is seeking an experienced Medical Monitor Consultant to provide medical oversight across multiple early‑phase oncology clinical trials. This individual will serve as a key medical and scientific resource, supporting ongoing Phase 1, Phase 2a, and Phase 2b immuno‑oncology studies focused on solid tumors. The Medical Monitor will work closely with investigators, clinical operations, safety, and cross‑functional study teams to ensure subject safety, protocol compliance, and high‑quality study execution. The ideal candidate will have prior experience supporting early‑phase oncology programs within a biotech environment and thrive in a lean, fast‑paced, collaborative culture. This is a contract opportunity with the potential to convert to a permanent position for the right candidate.

Responsibilities

• Provide protocol‑level medical monitoring and oversight for multiple oncology clinical studies.
• Serve as the primary medical resource for study teams, investigators, CROs, and other external partners.
• Review and evaluate safety data, adverse events, serious adverse events, and emerging risk signals.
• Support ongoing assessment of patient eligibility, protocol deviations, and study conduct issues.
• Collaborate with investigators to address medical questions and ensure patient safety throughout trial participation.
• Participate in safety review meetings, data review activities, and study team discussions.
• Assist with the development and review of study protocols, informed consent forms, medical monitoring plans, and other clinical documents.
• Contribute medical expertise to dose‑escalation decisions, safety monitoring committees, and risk management activities.
• Partner closely with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, Biostatistics, and Data Management teams.
• Support regulatory submissions, study reports, and other clinical development activities as needed.
• Ensure study conduct adheres to GCP, ICH guidelines, protocol requirements, and applicable regulatory standards.

Required Qualifications

• MD, DO, or internationally equivalent medical degree.
• Significant experience serving as a Medical Monitor or Clinical Development physician within biotechnology, pharmaceutical, or CRO environments.
• Demonstrated experience supporting early‑phase oncology clinical trials, including Phase 1 studies.
• Strong expertise in immuno‑oncology and solid tumor drug development.
• Experience reviewing safety data and supporting ongoing benefit‑risk assessments.
• Working knowledge of clinical trial regulations, GCP, ICH guidelines, and pharmacovigilance processes.
• Ability to effectively collaborate with investigators, study teams, and executive leadership.
• Excellent communication, clinical judgment, and problem‑solving skills.

Preferred Qualifications

• Experience in small or emerging oncology biotechnology companies.
• Prior involvement with Phase 1, Phase 2a, and Phase 2b oncology programs.
• Background in immunotherapy, targeted therapies, or novel oncology mechanisms.
• Ability to function effectively in a lean, hands‑on environment where team members contribute across multiple areas.
• Proximity to the Greater Philadelphia area and willingness to attend occasional onsite meetings preferred.