Senior Clinical Scientist – Oncology Clinical Development

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.
Requirements
PhD, PharmD, MS or equivalent degree, preferably in medical, biological, pharmaceutical sciences or a related discipline.
At least six years of clinical research experience including significant drug development experience
Prior oncology or haematology drug development experience.
Experience working effectively within a matrix-team environment.
Excellent oral, written and interpersonal communication skills.

Work arrangement
Yes