Head of the safety department and overall responsible for safety surveillance, signal detection and risk management activities/processes during drug development and post-marketing.

Transformed the department from consultant led operational activities to internal led with focus on the evaluation of the safety profile of Y-mAbs products.- Led development of product safety monitoring and risk management- Lead of Data Monitoring Committees (DMCs) and chairing the internal Safety Committees - Part of the BLA team for naxitamab (GD2 targeting antibody) for the treatment of high-risk neuroblastoma leading to FDA approval of Danyelza in 2020- Part of the BLA & MAA team for 131I-omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma. The application to FDA failed after negative opinion regarding proof of efficacy from the advisory committee at the ODAC meeting with FDA in Q4 2022

Headhunted from Genmab to build a safety department in Y-mAbs, maintain drug safety expertise, develop, and execute drug safety oversight for Y-mAbs products. - Interaction with a Clinical Research Organisation (CRO) on outsourcing of safety deliverables- Evaluation of important safety signals and associated responses to regulatory authorities- Established and chaired the internal Safety Committees- Leading the interactions with multiple DMCs- Authored/reviewed trial related documents e.g. annual reports, IB, protocols, ICF- Authored and implemented Y-mAbs SOPs

- Safety representative for two oncology products in early development- Responsible for surveillance, signal detection, and introduction of risk mitigation activities- Leadership of the Safety Committees - Interactions with the DMCs- Investigator meeting presentations - Authored/reviewed trial related documents e.g. annual reports, IBs, study protocols, ICFs, CSRs

Involved in the outsourcing of safety operation activities to a CRO. Responsible for:- Medical evaluation of AEs- Surveillance of summarized safety data, signal detection, risk mitigation activities- Interactions with the Data Monitoring Committees (DMCs) and leading Safety Committee meetings - Training activities for investigators, CROs - Review of eCRF and edit checks- Prepared/reviewed of trial related documents e.g. annual reports, IBs, protocols, ICFs, CSRs- Member of SOP committee, ensuring alignment across SOPs- Member of Regulatory Intelligence Forum (surveillance and implementation of safety related regulatory guidelines)

Worked with early clinical development of antibody-based drug candidates for the treatment of patients with cancer (among others; B-cell chronic lymphocytic leukemia (targeted towards CD20 receptors), head & neck-, lung- and colon cancer (targeted towards EGR receptors), multiple myeloma (targeted towards CD38 receptors), metastatic cervical cancer (targeted toward tissue factor receptors). Main responsibilities: Medical evaluation of adverse events, participated in DMC & Safety Committee meetings, member of the safety management teams after partnership with Janssen, reviewed SOPs and guidelines, participated in audits and inspections.

Data entry and medical evaluation of adverse events from clinical trials within the therapeutic areas of diabetes, haemostasis, growth hormone, haemophilia in addition to post-marketing and literature cases. Submission of SUSARs to regulatory authorities, reconciliation, presenter at CRA training and investigator meetings and participated in FDA inspection without findings.