Basel, Basel, Switzerland
I am an experienced drug developer from early stage drug discovery until commercialization of biosimilars and orphan drugs. I am an outcome-focused individual who consistently delivers strong results at both on individual and team level. I am a performance driven, disciplined and passionate PhD level professional. Managing cross-functional, multi-cultural, international development teams in oncology and supportive care. I worked on programs from clinical stage, via submission / approval until post-launch activities. In alignment with my diplomatic working style, I have demonstrated to be a strong team-player, encouraged by my ability to build trust and strong relationships with teams. I’m highly agile & pragmatic with strong experience in a large matrix organization. Additionally I always create a connection between ideas, plans and peoples.
- Build and establish program and project management from ground up with in science and innovation
- Managing of a development program and a marketed product - Leading a development sub-team - Defining the strategy within the project teams - Preparing project specific project plan - Plan budget and track ongoing project related costs - Review of documents for the interaction with EMA, FDA, MHRA
- Forecasting and tracking of clinical supplies to ensure that clinical sites are operational for patient visits throughout the course of clinical trials - Design and implement strategies to supply study drug to global clinical trials using sound supply chain techniques - Manage studies by leveraging the inventory management capabilities of Interactive Response Technology (IRT) - Manage the long-term drug supply planning of studies by use of Simulation System - Knowledge in GMPs & GCPs
- Managing of biosimilar development programs - Leading a development sub-team - Defining the strategy of two biosimilar products Zarx(z)io & Ziextenzo within the project teams - Preparing project specific project plan - Plan budget and track ongoing project related costs - Preparation of a workshop within cross-functional team to accelerate submission timelines to FDA for Ziextenzo - Review submission documents to health authorities for Ziextenzo (EMA / Health Canada / FDA)
- Operational support of Global Program Leader - Preparing a summary of the development strategy for a Alliance Program
- Organizing and facilitating of cross-functional meetings, VCs, TCs as well as major F2F events with US scientific consultancy company - Supporting the team in preparing key documents for Health Authority Meetings - Support for contracting of external consultants