The Hague, South Holland, Netherlands
• Energetic, creative, analytical with a focus to deliver. Authentic multiplying leadership style with the aim to maximize the contribution and development of the team. • Medical Doctor with significant experience in clinical development and medical affairs in the pharmaceutical industry in the field of in cardiovascular disease, diabetes mellitus, oncology, respiratory disease • 10+ years’ leadership experience - direct reports, matrix teams clinical/medical projects and programs • Solid relationships with national and international KOLs • Track record of multiple regulatory submissions and regulatory defense meetings with health authorities
Temporary assignment to provide medical scientific support for the clinical development plan
Medical Director, AstraZeneca Netherlands 3 Therapeutic areas; Cardiovascular / Metabolism, Oncology, Respiratory Key responsibilities • Medical strategy of the 3 therapeutic areas • Line management, 5 direct reports with total span of control 30+ employees • Regulatory Affairs department Achievements • Remodelling medical organization • Introduction of medical excellence • Integration of brand strategy- and medical plans • Successful launches and indications of new product in all TAs
The BRILINTA development program consist of 5 indication seeking cardio vascular outcomes studies ranging from 13.500 to 21.000 patients per study. Key responsibilities • Leadership of the cross functional Global Product Team 10+ functional representatives. (clinical science, clinical operations, regulatory affairs, medical affairs, biostatistics, project leaders, patent law, legal council) • Develop and present lifecycle investment cases for endorsement at Senior Executive Team / Late Stage Portfolio Committee • Line management, 3 direct reports • Maintenance of the Integrated Product Development Plan • Identify and deliver External Sponsored Research (ESR) program. Achievements • CEO award for fastest submission of indication seeking study outcomes study in the history AZ (6 weeks) • Streamlining ESR program • Reorganizing governance model for optimal development and commercial integration
Development of PCSK9 (Cardiovascular disease / dyslipidaemia) Development of aleglitazar (Cardiovascular disease / diabetes mellitus) Development of dalcetrapib (Cardiovascular disease / CETP inhibitor) Key reponsibilities • Deputy Clinical Science Leader • Clinical development of anti PCSK9 phase 3a CV mega outcomes study (18.000 patients) / Clinical development of aleglitazar phase 3b CV mega outcomes study (19.000 patients) • Lead responsible for the development of the phase 3b clinical program of dalcetrapib (targets several supplemental New Drug Applications). o For the studies under this program I sit in the Executive Committees. o In this position I delivered 3 studies including 1 CV mega outcomes study (20.000 patients) • Clinical Science representative for Medical Affairs and Global Product Strategy • Line management of 2 Clinical Science Specialists and 2 Clinical Scientist Achievements • Innovative imaging study design development • Optimization of CV outcome study set up resulting in predictable superfast recruitment • Set up of on-boarding curriculum