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Summary

Twenty-year experience on drug development in pharmaceutical industry. Preclinical, clinical development phases and registration in various therapeutic area (Immune-Oncology, Oncology, Dermatology, Fertility, Endocrinology using Gene Therapy, Cancer Vaccine, Antibodies and Small Molecules), combined with 10 years of basic research in Immunology and Oncology. I am curious, enthusiastic, dynamic, reliable, decisive, and flexible My leadership style is collaborative and participative. Recently, I managed multidisciplinary and multicultural teams, obtaining regulatory CTA approval for clinical trial execution in EU and successfully implemented the activities necessary to transition molecules from preclinical to late development. 

 
In my next career step, I am looking forward to similar challenges

 Specialties: 
• Global Cross-functional Team leadership, multicultural, remote 
• People management, Influencing with and without direct reporting • Clinical leadership skills managing phase I, II III multicenter clinical studies • Clinical Safety experience in various therapeutic areas

Experiences

Current Experience

  • Pharmaceutical Development and Project Leader Independent Consultant
    Since September 2016

Past Experience

  • Chief Operating Officer
    June 2015 --- September 2016
    Overseeing the company development activities from preclinical to clinical development, responsible for setting up and lead the development plan execution.

  • Director
    May 2007 --- October 2013
    Lead cross-functional manager teams to create and implement Product Strategies for development pipeline and Life Cycle projects, ensuring cross-functional integration of all involved functions. Accountable for all team decisions/proposals.

  • WW Senior Clinical Safety Manager
    January 2004 --- July 2007
    Provide safety expertise to support project development as core team member in Global Project teams

  • Medical Research Specialist and Clinical Trial Leader
    January 2000 --- January 2004
    Lead Clinical Operational teams encompassing medical, regulatory, data management, safety and commercial. Multi centre Phase I, II and III clinical trials (EU, USA, CAN, Asia) in Endocrinology, Dermatology, Autoimmune disease

  • Medical Research Associate
    May 1997 --- January 2000
    Phase II and III Multicenter Clinical trial budget management Legal contracts stipulation, review and follow-up Protocol writing and CRF design Data cleaning, queries and resolution

  • Visiting Investigator
    November 1991 --- October 1996

  • Visiting Investigator
    November 1989 --- November 1991

  • Research Fellow-American-Italian Foundation
    December 1987 --- November 1989

  • Visiting Investigator
    March 1985 --- January 1986

Personality

Self Assessment :
AdaptabilityAssertivenessAuthenticityCollaborationCommunicativeCritical thinkingCuriosityIndependenceInnovative thinkingInterest in knowledgeFlexibilityProactivityProblem solvingResiliencyStrategic thinkingTrust

Knowledge

Self Assessment :
Cell biology Negotiation Phase I R&D Scientific writingAdverse Events (AE)AngiogenesisBiological Drug DevelopmentBiologyBiomedical SciencesBiopharmaceuticalsBiotechnologieBiotechnologyBudget ManagementBudget NegotiationBusiness DevelopmentBusiness ProcessesBusiness StrategyCancer ResearchCell biologyClinical DevelopmentClinical operationsClinical researchClinical Study DesignClinical study reportsClinical trial budgetingClinical trial designClinical trialsCoachingCommunication SkillsCRFCell CultureCRF designCross-functional team leadershipData AnalysisDermatologyDeveloping Clinical Trial ProtocolsDNADNA extractionDNA sequencingDrug DeliveryDrug DevelopmentDrug Safety and PharmacovigilanceDrug safety assessmentDue DiligenceEarly development stageEndocrinologyEndocrinology and metabolismEntrepreneurshipEvent ManagementForecastingGene therapyGood Clinical Practice (GCP)
LinkedIn Assessment :
Project ManagementsciencemanagementLeadershipSafetyCross-functional team leadershipClinical DevelopmentoncologyGCPClinical trials21 CFR Part 11Drug DevelopmentPharmaceutical IndustryCTMSPharmacovigilanceImmunologyEndocrinologyCRODermatologyRegulatory RequirementsBiotechnologyBiomarkersFDALifesciencesBiopharmaceuticalsInfectious diseasesRegulatory submissionsRegulatory affairsMedical writingLife SciencesClinical researchTherapeutic AreasVaccinesDrug DiscoveryStrategy

Skills and Expertise

Self Assessment :
Analytical skills Build and manage the Trial Master File (TMF) Create SOPs Develop clinical trial protocols Develop protocols Interact with physicians Interpret data Report data Search literature on clinical trials Build the CMC development plan Write papers Write protocolsAdvise on strategy

Education

  • Doctor of Philosophy (Ph.D.) in Cellular Biology from University of Geneva in 1995
  • Dottore in Microbiology and molecular biology from Università degli Studi di Genova in 1985
  • Laurea in Biological Sciences from Università degli Studi di Genova in 1985
  • in from Liceo classico Colombo in 1978

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Italian
Native
French
Full Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    R&D Director Business Consultant Global PM Team Leader Account Manager
  • Positions I am NOT interested in:
    Assistant
  • Locations I am interested in:
    France Germany Italy Switzerland UK
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    50-100% FTE
    BrightOwl freelancer :    35 Hours per week
    BrightOwl employee :    50-100% FTE
  • International:
    Yes

Area / Region

Geneva, Switzerland

Others

Driving License
  • No