Global management of international clinical trials: Ph. IIb and IV• Cross-functional team coordination (regulatory affairs, clinical supply, data management, purchasing, safety, statistics, QA, PK/PD experts)• Protocol and study-document writing• Selection of service providers, budget negotiation• Trial feasibility, site selection and qualification• EC/IRB/HA submissions• CRA training, investigator meeting• Study follow-up, reporting, budget• CRO management (monitoring, IVRS, ECG central reading, clinical photography, central lab, medical writing)• Study closure• Results analysis and presentations (CSR, results slide kit)Observational patient surveys, collection of patient testimonials, management of cosmetic studies

Medical responsible for products in diabetes, haemophilia and growth hormone deficiencyMedical information, education of external and internal staff, clearing of promotional materials (collaboration with Marketing), safety surveillance, new products launch preparation (medical and pricing aspects), organisation of advisory boards, observational studiesMarket access : preparation of reimbursement dossier in Switzerland and price negotiation, follow-up on price reviewsAchievements: 4 new products reimbursed and launched

Country level trial management & monitoring of phase 2 and 3 trials in Switzerland (within global trials)Site selection and feasibility, trial set-up, submissions to ethics committees and health authorities (Swissmedic, BAG), clinical site management, monitoring, budget and contract preparation and controlling, site closure, Country Trial Master File (from set-up to archiving)Trial phases: 2, 3aTherapeutic area: diabetes (type 1 and 2), haemophilia AAchievements: trial approval and FPFV achieved in a timely manner, excellent site data quality (audit)

Global management of 2 phase 2a trials (Europe & USA), from FPFV to study report and out-licensing of projectCoordination of out-sourced trial-related activities, analysis of clinical data, protocol and study report preparation, regulatory affairs (annual reports), budgeting, project planning, project progress reporting, Trial Master FileCMO selection and contract negotiationPreparation and presentation of data for due diligencesTrial phases: 1/2a Therapeutic area: OphthalmologyAchievements: project successfully out-licensedProject management: cross-functional team coordination, project planning, budgeting, preparation of project reports, scientific advice briefing documentsPhase: pre-clinicalTherapeutic area: Inflammation

Global management of 2 projects, from end of phase 1 to site initiation (Europe & USA)Project management: cross-functional team coordination (regulatory affairs,clinical and medical operations, manufacturing, business development, quality), project planning, budgeting, project progress reportingPreparation of project documentations: preclinical study reports, investigator's brochures, pre-IND package (participation to a pre-IND meeting at the FDA), IND/IMPD Trial phases: 2aTherapeutic area: Wound healingAchievements: timely approval of trials, sites ready for FPFV, team motivated

Development of pharmaceutical products and biodegradable medical devicesFormulation development and in vitro experiments for support of clinical trial applications to authorities and medical device technical file.Pre-clinical report preparation and review, investigator's brochures pre-clinical sectionDevelopment and validation of analytical methods (transfer to third parties (CMO))Stability testingPreclinical studies (mainly pharmacology studies)Risk assessment and risk management planTherapeutic areas: wound healing (acute and chronic wounds, brain surgery)Laboratory manager: responsible for lab organisation and general task attribution, orders, contact with product and service providersAchievements: final formulations developped and tested in Phase 1 and 2 trials, stability data generated for medical device technical file

Topic: DNA repair and cell cycle control- Production and purification of recombinant proteins in E. coli- 3D structure of protein domains using NMR- Identification of interaction partners (proteins, peptides, DNA), characterization of interactions

Topic: DNA repair and cell cycle control- Production and purification of recombinant proteins in E. coli- Structural biology

Internship in a start-up in Health Canada (Ottawa)Assay development to detect wheat allergens in food products (ELISA)

InternshipOral administration of insulinPhysico-chemistry of colloids, NMR titrations, analysis of in vivo results

Internship