Medical Monitor, Oncology

Position Overview

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.

Key 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.