Key Responsibilities

• Work closely with the Medical Director to support the clinical development strategy for assigned trials and compounds.
• Lead development of the Medical Data Review Plan (MDRP), conduct ongoing clinical data review, and summarise safety and efficacy data to support interpretation and analysis.
• Support early phase study activities, including preparation for and coordination of Dose Escalation Committee meetings and related presentation materials.
• Prepare charters and coordinate internal and external committee meetings, including Dose Escalation, Data Monitoring, Steering and Safety Committees.
• Provide scientific input into eCRFs, eCRF completion guidelines, data management deliverables, protocol deviation review, coding, and database lock activities.
• Contribute to study plans and work closely with project teams and CROs to support study delivery.
• Contribute to clinical and regulatory documentation, including protocols, informed consent forms, Investigator’s Brochures, annual safety updates, study reports, briefing documents, INDs, and clinical dossiers.
• Provide medical input into country and site selection, feasibility assessments, and Key Opinion Leader (KOL) interactions.
• Contribute to publications in collaboration with Scientific Communications and support training at investigator meetings, CRO/CRA training, and site initiation visits, as required.