Senior Medical Director, Clinical Development

Medical Director, Clinical Development – Solid Tumor Oncology

Meet Life Sciences is representing a mid-size biotech seeking a Medical Director to support its late-stage solid tumor oncology portfolio. This physician will serve as the senior study physician for a pivotal Phase 3 trial, providing medical leadership, hands-on medical monitoring, and oversight of clinical data throughout study execution.

This opportunity is suited to an oncology physician who enjoys working closely with investigators and cross-functional teams to deliver a high-quality registrational study.

Key Responsibilities

• Serve as the senior study physician and medical lead for a pivotal Phase 3 solid tumor oncology study.
• Lead day-to-day medical monitoring, including review of patient eligibility, adverse events, laboratory findings, efficacy assessments, and protocol deviations.
• Act as the primary medical contact for investigators, addressing clinical questions and supporting consistent protocol interpretation across study sites.
• Partner with Drug Safety to assess serious adverse events, evaluate emerging safety signals, and implement appropriate risk mitigation measures.
• Conduct ongoing clinical data review to identify trends, resolve discrepancies, and support data quality and interpretation.
• Provide medical input into protocol amendments, investigator brochures, informed consent forms, clinical study reports, and regulatory documents.
• Collaborate with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Drug Safety to support study delivery and key milestones.
• Support preparation for data monitoring committee meetings, interim analyses, database lock, and final study reporting.
• Contribute to regulatory submissions and responses to health authority questions.
• Build relationships with investigators and external oncology experts, and present study updates at investigator meetings and internal reviews.

Qualifications

• MD or equivalent medical degree required.
• Fellowship training in medical oncology or hematology/oncology; board certification or eligibility preferred.
• Pharmaceutical or biotechnology clinical development experience, including direct responsibility for medical monitoring of oncology trials.
• Experience supporting late-stage solid tumor studies; Phase 3 or registrational trial experience strongly preferred.
• Strong understanding of oncology clinical practice, response assessment criteria, clinical trial methodology, and safety evaluation.
• Working knowledge of ICH-GCP and applicable regulatory requirements.
• Ability to interpret complex clinical data and make sound medical decisions.
• Strong communication skills and experience collaborating with investigators, CROs, and cross-functional study teams.

Preferred Experience

• Prior experience as a study physician or medical lead for a global Phase 3 oncology trial.
• Experience supporting regulatory submissions, clinical study reports, or health authority interactions.
• Experience working within a small or mid-size biotechnology company.