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Summary

executive summary

Experiences

Current Experience

  • Senior Project Manager (PM)

    Halle (Saale), Germany
    Since January 2015

    major responsibilities

    • managing therapeutic antibody progrmas from candidate selection to early Clinical Development
    • establishing overall program timelines, milestones and Budgets in alignment with company Strategy
    • designing and contracting cmc, pk/tox and regulatory studies with external cros and academia
    • scouting for business in/out Licensing opportunities
    • review competitive landscape

    Major Responsibilities

    • Managing therapeutic antibody progrmas from candidate selection to early clinical development
    • Establishing overall program timelines, milestones and budgets in alignment with company strategy
    • Designing and contracting CMC, PK/Tox and regulatory studies with external CROs and academia
    • Scouting for business in/out licensing opportunities
    • Review competitive landscape

Past Experience

  • Head of Therapeutic Development Ghent, Belgium

    September 2011 --- December 2014

    major responsibilities

    • advancing novel Protein scaffolds as therapeutic agents into Clinical Development
    • managing production (cmc), regulatory (ind, emea), pk/tox and efficacy studies with external cros and internal resources
    • defining and monitoring overall company program timelines and Budgets
    • managing company goals as a Member of the senior management team
    • identifying business in/out Licensing opportunities and Research collaborations

  • Senior Director Munich, Germany

    September 2005 --- August 2011

    major responsibilities

  • Senior Scientist Boston, MA, United States

    May 2000 --- August 2005

    major responsibilities

    • Preclinical development of antibody/cytokine fusion Proteins (immunocytokines) against solid tumor targets
    • evaluation of optimized lead candidates with reduced tox profiles in Animal models
    • Member of management tam responsible for new product pipeline
    • assessment of ip opportuities with optimized lead candidates
    • establishment of immuno-Assays to monitor tumor-specific immune responses

  • Post-doctoral Fellow Boston, MA, United States

    June 1995 --- April 2000

    major responsibilities

    • molecular  and cellular Analysis of t Cell inflammatory and Cell death (apoptosis) processes In Vitro and In Vivo
    • generating transgenic mice to analyze t Cell-dependent inflammatory responses
    • Publications in top-ranked peer-reiewed journals

Personality

Self Assessment :
Attention to detailCollaborationCommunicativeDiligenceCreative thinkingCritical thinkingDependabilityFlexibilityOrganizationProactivitySociabilityStrategic thinking

Knowledge

Self Assessment :
- responsible for advancing novel therapeutic programs (antibodiesscaffoldsfusion proteins from discovery into clinical development Phase I R&DAntibodiesBiological Drug DevelopmentBiotechnologyBudget ManagementBudget NegotiationCancerClinical DevelopmentClinical Study DesignClinical trial managementCross-functional team leadershipCMC Contract negotiationFDAImmunologyEnglishInflammationKnowledge of the drug development processMicrosoft OfficeoncologyPharmaceutical IndustryPatentsUnderstanding of regulatory guidelinesUnderstand levels of research evidenceStrategic PlanningRegulatory submissionsProject ManagementPre-clinical researchPhase IINDIMPD

Skills and Expertise

Self Assessment :
Analyze data Build the CMC development planAssign activitiesbudgeting of R&D activitiesCollaborate with medical teamContract approvalDesign scientific projects (in biology)Develop regulatory strategyEvaluate licensing opportunitiesIdentify investigatorsInteract with CROs

Education

  • Ph.D. in Immunology from University of Toronto in 1995
  • BSc in Immunology from University of Toronto in 1989

Training and Certification

  • Advanced Business Development in 2013 Certification
  • Toxicology Compact in 2008 Certification
  • Biotechnology Project Management in 2004 Certification

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Professional Proficiency

Work Preferences

  • Notice Period:
    7 weeks
  • Positions I am interested in:
    CSO Scientific consultant Managing Director
  • Work From Home:
    Yes, 5 to 0 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Berlin, Germany

Others

Driving License
  • Yes

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