Dr. Nicole Filser
Selbstständig, Consultant, VORCET
Zuerich, Schweiz
Werdegang
Berufserfahrung von Nicole Filser
Bis heute 12 Jahre und 5 Monate, seit Feb. 2012
Consultant
VORCET
Consultancy in pharmaceutical industry and clinical research organization for clinical development and development strategy, regulatory authority advices, clinical operations and Project management
2 Jahre und 7 Monate, Nov. 2013 - Mai 2016
Senior Clinical Project Manager
Auris Medical AG
Main responsibilities: • Project management of the product development of an orphan drug • Selection and contracting CROs and other vendors • Writing protocols and relevant study documents • Scientific advice and IND procedures; writing the clinical parts • Overview on overall project from CMC to CTD planning Major achievements so far: Validation of the development plans at FDA and EMA, trial setup and start within planned timelines and budget Therapeutic Areas: Neurology
1 Jahr und 11 Monate, März 2010 - Jan. 2012
Senior Director Clinical Development
Mylan GmbH
Main responsibilities: • Built-up lean functional clinical team; line management of 4 people • Established interfaces and collaborations • Set-up development plans and ensured successful validation with international health authorities • Vendor selection and contracting; set up of project management Major achievements: set up functional clinical team, validated development plan for first biosimilar monoclonal antibody Therapeutic Areas: Oncology, Immunology
7 Jahre, März 2003 - Feb. 2010
Head of Development
BioPartners
Main responsibilities: • Led and expanded the clinical operations department with internal and external stakeholders • Successful EMA and FDA inspections • Led clinical development of biosimilars, new and generic drugs • Accountable to investors and the board • Regulatory affairs tasks included CTD writing and presentation to the authorities (1 Biosimilar and + generic product) • Project- and line management (5 people)
2 Jahre und 1 Monat, Feb. 2001 - Feb. 2003
Project Leader and QPPV
Amersham Health
3 Jahre und 6 Monate, Aug. 1997 - Jan. 2001
Clinical Research Scientist
GlaxoWellcome
3 Jahre und 8 Monate, Dez. 1993 - Juli 1997
PhD, Scientist
Federal Institute of Technology (ETH)
Ausbildung von Nicole Filser
Molecular Biology
Universität
Sprachen
Deutsch
Fließend
Englisch
Fließend
Französisch
Fließend
Italienisch
Grundlagen