Experteer Overview
In this role you will provide scientific and clinical input to oncology trials across early and late development, shaping study design and data interpretation. You will collaborate with cross‑functional teams to build robust development plans, review trial data, and support regulatory communications. You’ll contribute to medical data review, SIVs, safety committees, and abstracts/presentations for scientific conferences. This role offers impact by guiding evidence generation and regulatory interactions in a fast‑paced oncology setting.

Compensation / Benefits
• Collaborate with cross‑functional study teams (medical, safety, operations, statistics, precision medicine, pharmacology, regulatory) to execute clinical studies
• Partner with Medical Director to strategize and design innovative development plans and trial designs
• Develop and maintain clinical trial protocols, manuals, and study reports
• Review informed consent, lab manuals, CRF designs, clinical query design, and deviations
• Prepare materials for SIVs, Investigator Meetings, and Safety Review Committees
• Regularly review the clinical database and identify trends needing escalation
• Review and validate clinical study reports and regulatory documents (IB, DSUR, responses)
• Provide scientific support for regulatory filings and health authority interactions
• Author internal documents, abstracts, posters, and conference presentations
• Provide asset development updates to management as appropriate

Tasks
• Advanced Clinical/Science Degree (e.g., MD, PharmD, PhD, MSN)
• Minimum 5 years experience in clinical science/research/development in oncology
• Proficient in oncology data analysis, safety/efficacy interpretation, GCP/ICH, study design, statistics, biomarkers, pharmacokinetics, clinical operations, and regulatory requirements
• Strong written and oral communication to diverse audiences
• High organizational and project management skills
• Ability to work autonomously and professionally

Key requirements
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