Core responsibilities:- Vendor management of non-clinical studies- Operational support for NCS Team Lead regarding development and organizational tasks- Support the non-clinical safety strategy of cross-functional program teams during different stages of development to meet respective program and company milestones- Generate and review safety assessment reports for first-in-class immunotherapeutics to guide decision-making on clinical and regulatory strategyOther responsibilities include:- Diligently review, finalize and archive raw data and study reports from CROs- Act as point of contact for external vendor and consultancy for all non-clinical studies- Contributing to critical modules for regulatory interactions and submission packages- Contribute to development of program strategy and decision-making- Contribute to key program documents- Ensure complete and targeted communication with the Team- Responsible for non-clinical program budget incl. regular forecasting as requested- Preparation and review of SOPs

Tasks:•Administration and preparation for trial set up, monitoring and tracking•Maintaining tracking databases•Maintaining project files and documentation according to Standard Operating Procedures and Working Practices•Assisting in the organisation of project team and client meetings•A variety of additional tasks in line with business and department needs

Tasks:• In-house site management in accordance with good clinical practices • Respond to ad hoc site requests for assistance• Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS) to ensure adequate communication to project team and sponsor• Play an active role within the clinical team to help reach project goals, achieve deliverables, and meet project timelinesStudies:• A phase II pivotal breast cancer study• Two phase III MDS studies

Tasks:• Provided project administrative support to Clinical Team Manager, Remote Side Monitors, and Clinical Research Associates• Assisted in preparation and submission of Ethics Committee packages • Assisted in preparation and submission of Clinical Trial Agreements• Maintained Trial Master File and Clinical Trial Management SystemStudies:• A phase II non-small cell lung cancer study• A phase III melanoma study (rescue study)• A pivotal breast cancer study (during start-up)Received training on ICH-GCP, Clinical Trails, and Monitoring

Genome-wide analysis of inter-individual variability in cytotoxicity on exposure to anticonvulsant and evaluation of possible association to drug-induced hypersensitivity reactions

Cultured and successfully screened immortalised cell lines from healthy volunteers in a semi-automated high throughput screening. The inter-individual variability was subsequently analysed to discover new biomarkers by means of a genome-wide association study.Courses:Genetic EpidemiologyMethods in PharmacogenomicsPrinciples of Experimental Analysis