Calluna Pharma, a clinical stage company specialising in creating therapeutics for inflammatory and fibrotic diseases, has appointed Margrethe Sørgaard to the position of Senior Vice President (VP) of Clinical Operations and Pharmacovigilance.
Margrethe joins the Company’s cross-functional R&D team following Calluna’s launch, to oversee the strategic development of the Company’s clinical programs in line with regulatory guidelines and safety requirements.
With over 25 years’ experience from different leading positions in clinical development and operation, medical affairs and drug safety/pharmacovigilance, Margrethe will play a pivotal role in supporting the development of Calluna’s clinical programs including CAL101, the Company’s lead product as it enters Phase IIa clinical development.
As a Senior VP of Clinical Operations and Pharmacovigilance, Margrethe will be responsible for clinical operation activities pertaining to product safety and pharmacovigilance, ensuring appropriate safety assessment and surveillance, compliant regulatory authority reporting and the development and implementation of risk management strategies. She will also oversee CRO activities and tasks related to patients’ safety in clinical studies.
Margrethe joins Calluna from BioInvent International AB where she was the Senior Director of Safety and PV, supporting product safety and assuring safety standards were compliant with global drug safety regulations.
Prior to this, Margrethe was the VP and Head of Clinical Development at Circio Holding ASA, and has previously gained experience in regulatory pre-and post-marketing processes and quality assurance, by serving as an EU Qualified Person for Pharmacovigilance (QPPV) while at Photocure ASA, and Head of Unit for Safety Assessment and GCP/PhV inspector at the Norwegian Medicines Agency (NOMA).
John Montana, PhD., Chief Executive Officer of Calluna Pharma, commented: “We look forward to leveraging Margrethe’s expertise in all aspects of clinical development and clinical operations, to help ensure Calluna’s clinical programs run according to the company’s strategy, applicable legislation, regulations, and guidelines, while prioritizing patient safety.”