Don’t consider the below a restrictive list. My intention is to combine all my passions and ambitions and keep learning. So don’t withhold and surprise me with a new challenging project that needs peak performance.
Past experiences & achievements:
- Strategy creation and change management: cocreated full-blown strategy for two merged hospitals
- Business development: Created business case for global roll out of critical phase Project Management approach, including benchmarking data
- Process implementation + team/compound specific translation:
Pro-actively outlined Pre-submission processes, End of Phase I processes, Post-submission processes and Pediatric processes
- Process and Continuous improvement: Optimized crossfunctional processes (process excellence DMAIC approach). Worked with project teams to find solutions to improve their processes ‘on the go’
- Team collaboration and bridging: worked closely and organized workshops with various internal and external partners as Clinical, Medical, Regulatory, Safety, Medical Writing, Statistics, Health economics & Pricing, research teams in operating companies, European multifunctional brand teams and their leads.
- Process and Organizational design: Created generic Pediatric pre-submission process (PIP); guided management to solve gaps in cross-departmental processes and organizational structures
- Contract negotiation: successfully negotiated budget with market research and clinical vendors
- Guided and coached compound development teams in implementation of process improvements and focus on critical path milestones; lead them to high performance
- Clinical team management: planned, set-up, implemented, (vendor) managed and coordinated phase I (First In Men), II (Proof of Concept and QTc), and III clinical trials and Expanded Access Programs with investigational Infectious Diseases drugs in line with the Clinical Development Plan (content, planning and budget) and applicable guidelines (ICH, regulatory authorities)
- Leveraged learning throughout the company by training and communication
- Developed creative but solid strategies and approaches to demonstrate the value of, and broaden access for Oncology products. Monitored and drove the implementation of agreed upon launch and lifecycle strategies in the EMEA region.
- Maintained and improved product value propositions, dossiers and supportive evidence after launch. Leveraged best practices across EMEA. Directed multifunctional projects to optimize market access, pricing or reimbursement.
- Market Access issue management: supported operating companies with HTA Oncology reviews during the entire product lifecycle.
- Clinical management and monitoring: Set up and monitored First In Human studies with investigational Diabetic, Obesitas and HIV drugs
- Data management: Did critical data entry + clean-up of study databases