Associate Medical Director / Medical Monitor - Remote Position

Major Duties / Responsibilities

• Provide medical leadership for the design, conduct, and oversight of Phase I–IV clinical studies in oncology.
• Serve as Associate Medical Director / Medical Monitor for ongoing clinical trials, including:
• patient eligibility review,
• protocol deviation assessment,
• safety signal evaluation,
• dose modification guidance,
• and ongoing medical oversight throughout study conduct.
• Contribute to development strategy and study design, including endpoint selection, biomarker integration, and translational research components.
• Review and interpret clinical data, including efficacy, safety, PK/PD, biomarker, and translational datasets.
• Participate in data review meetings, safety review committees, dose escalation meetings, and advisory boards.

Patient Safety And Compliance

• Ensure patient safety, data integrity, protocol compliance, and adherence to ICH-GCP and applicable regulatory requirements.
• Contribute to benefit-risk assessments and ongoing safety monitoring activities.

Skills, Abilities And Competencies

• Clinical trial design and execution
• Clinical data review and interpretation
• Safety assessment and benefit-risk evaluation
• Strategic thinking and scientific leadership
• Strong written and verbal communication skills
• Ability to effectively communicate complex medical concepts to diverse audiences
• Cross-functional collaboration and decision-making in a fast-paced environment
• Ability to manage multiple priorities and shifting timelines

Required Education And Professional Experience

• MD, DO, or equivalent medical degree
• 5–10+ years of experience in drug development, clinical research, clinical practice, academic medicine, translational research, or a combination thereof
• Strong understanding of clinical trial methodology, oncology drug development, and global regulatory requirements
• Knowledge of ICH-GCP and applicable FDA/EMA regulatory frameworks
• Excellent scientific communication and presentation skills

Preferred Education And Experience

• Prior experience as Associate Medical Director / Medical Monitor or Clinical Study Lead
• Experience in oncology clinical development, including breast cancer clinical research
• Experience with global and/or multicenter clinical trials
• Experience supporting regulatory submissions and health authority interactions