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CV | Birgitte Lassen

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CV | Birgitte Lassen PERSONAL DATA name Birgitte Lassen Rossau adress Bernstorffsvej 129, 1. 2900 Hellerup Denmark mobile +45 61 22 04 80 mail [email protected] date of birth 29.10.1965 EDUCATION 1992 MSc Pharm University of Pharmaceutical Sciences COMPETENCIES ▪ leadership ▪ project management ▪ partner relations and stakeholder management ▪ international co-operation and cultural awareness ▪ innovation and creative thinking ▪ strategic planning ▪ presentation and training EXPERIENCE 2017 - 2020 Clinical Trial Liaison – Europe Global Clinical Operations Regeneron through b. pharmaconsult ivs ▪ Supporting the global clinical development programs in various therapeutic areas across Europe as Lead Clinical Trial Liaison ▪ Engaging sites in patient recruitment activities ▪ Regeneron sponsor representative towards KOLs and Investigators ▪ Building relations with KOLs and Investigators ▪ Liaison between Regeneron, CROs and sites ▪ Developing the Clinical Trial Liaison role and tailoring the program support to ensure added value Page 1 of 5 01JUL2020 2017 - Founder of b. pharmaconsult ivs, Denmark 2014 - 2017 Director, Clinical Research and Operations Management Clinical Development and Regulatory Affairs Regeneron, EU HQ, Ireland ▪ Supporting the global clinical development programs in various therapeutic areas across Europe as Lead Clinical Trial Liaison ▪ Engaging sites in patient recruitment activities ▪ Regeneron sponsor representative towards KOLs and Investigators ▪ Building relations with KOLs and Investigators ▪ Liaison between Regeneron, CROs and sites ▪ Developing the Clinical Trial Liaison role and tailoring the program support to ensure added value ▪ Working with regulatory and commercial colleagues to focus on special needs for Europe ▪ Developing the Clinical Research Operations Manager role and tailoring the program support to ensure added value ▪ Building a team of Clinical Research Operations Managers to expand support across all TAs ▪ Member of cross functional Senior Leadership Team in Europe 2013 - 2014 Director, Clinical Study Management & Global Clinical Program Manager Daxas® Clinical Operations Takeda Pharma A/S ▪ Leadership of Global Clinical Study Managers ▪ Leadership of Global Clinical Program on Daxas® 2012 - 2012 Director, Clinical Trial Management, Daxas® Clinical Operations Nycomed: a Takeda Company ▪ Leading a group of International Clinical Project Managers and Clinical Trial Assistants conducting clinical trials and non- interventional studies with CROs 2010 - 2012 Director, Clinical Trial Management, Instanyl® Clinical Trial Operations Nycomed Page 2 of 5 01JUL2020 ▪ Leading a group of International Clinical Project Managers conducting clinical trials and non-interventional studies with CROs ▪ Supporting the group in CRO selection, negotiations, kick-off meetings, governance structure and escalation, operational excellence, finance, resource allocation - among many other tasks 2009 – 2010 Maternity leave 2006 – 2009 Director, LOC Coordination & International training Clinical Trial Operations Nycomed, Denmark and Germany ▪ Leading a group of employees across two R&D sites ▪ Responsible for implementation of Trial Management Organization in LOCs (Local Operating Companies) in “new” Nycomed ▪ Involved in selecting CROs as preferred partners and development of strategy for working with CROs ▪ Development of new training concept for Clinical Project Managers ▪ Member of Clinical Trial Operations Leadership Team 2005 - 2006 International Clinical Research Manager Clinical Operations Nycomed Group, Denmark ▪ Responsible for the establishment and development of a Clinical Trial Management Organization in affiliates ▪ Head the Clinical Trial Management Organization including training ▪ Responsible for calculation and allocation of resources to ensure optimal use ▪ Strategies for patient recruitment and retention in clinical trials ▪ Strategies for supporting the sales and marketing organization 2004 - 2005 Clinical Trial Manager/Medical Adviser Nycomed ApS, Denmark ▪ Responsible for conduct of clinical trials and non-interventional studies ▪ Medical support to Regulatory Affairs and Sales/Marketing Page 3 of 5 01JUL2020 2002 – 2004 Medical Marketing Manager Pfizer ApS, Denmark ▪ Responsible for design and implementation of international marketing activities and loyalty programs in relation to high profiled clinical studies ▪ Building relations to investigators 1999 – 2002 Clinical Study Manager Pfizer A/S, Denmark ▪ Project Manager on international study (IDEAL) including 8888 patients in CV ▪ Responsible for international marketing activities in relation to IDEAL 1994 – 1999 Clinical Study Manager Rhône-Poulenc Rorer, Norway ▪ Project management and monitoring of clinical studies in asthma and allergy 1993 - 1994 Ferrosan AS, Norway ▪ Responsible for establishing and maintaining the Medical Department 1992 – 1993 Clinical Research Associate Fisons A/S, Denmark ▪ Project management and monitoring of clinical studies THERAPEUTIC AREA EXPERTISE Respiratory ▪ Asthma phase POC, phase I, II, III – adult and pediatric ▪ COPD phase II, III, IV - adult Allergology ▪ Allergy phase I, II, III – adult and pediatric ▪ Eosinophilic Esophagitis phase II/III – adult and adolescent Neurology ▪ Epilepsy phase III - adult ▪ Alzheimer POC Cardiology ▪ Hypercholesterolemia/AMI phase IV Pain ▪ Break through cancer pain phase II, III ▪ PASS Page 4 of 5 01JUL2020 ▪ Epidemiology studies Psychiatry ▪ Schizophrenia POM Dermatology ▪ Atopic Dermatitis POM, phase II, III – adult and pediatric Skeletal ▪ Fibrodysplasia Ossificans Progressiva phase I, II/III - adult Oncology ▪ Biomarker studies EXTERNAL ACTIVITIES 2000 - 2013 External lecturer Pre-clinical and Clinical Development of Drugs University of Pharmaceutical Sciences 2005 – 2006 External lecturer Trial conduct from an organisational perspective MIND – Master in Industrial Drug Development University of Pharmaceutical Sciences 2005 – 2007 Course leader Clinical Trials and GCP Pharmakon 2004 Invited speaker Introduction to planning and conduct of clinical trials Danish Society of GCP 2001 Invited speaker Logistic opportunities and pitfalls in relation to large cardiovascular, multi-national, multi-center clinical trials First WHF Global Conference on CV Clinical Trials, Hong Kong 2001 External lecturer Course in Industrial Drug Development University of Pharmaceutical Sciences LANGUAGE CAPABILITY negotiation level English and Scandinavian tourist level German and French Page 5 of 5 01JUL2020 .
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