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Summary

experienced people- and result-oriented manager in Life Sciences - adding value and focus to development programs and teams. entrepreneurial, analytical, self-directed, strong drive; 20 plus years of international pharma experience. swiss and dutch citizen. cross-functional & and cross-cultural team lead; multi-cultural and multi-lingual (dutch, English, German) team-player. excellent Project Management skills - managing global projects including sucessfull nda submissions and approvals in both europe, usa and japan. CRO management. Line Management: managing a department of professionals (bsc to phd/MD level); creation of a new R&D department, including construction of Lab, recruitment of (foreign) staff, Qualification & Training. extensive experience in all relevant areas of Drug Development (Preclinical, Clinical phase 1-4, regulatory, cmc, Marketing and bd) in various environments (big and small pharma, biotech, cro and patient organization). Therapeutic Areas: Anesthesia; CNS/analgesia; Immunology; orphan drugs (neuromuscular; lysosomal storage disorders). specialties: strategic (cross-functional) team Leadership & global Project Management; Clinical and regulatory Strategy development; scientific collaboration, Innovation and creative Problem Solving; organizational transformation.

Experiences

Current Experience

  • Owner @QareFree [self-employed]


    Since October 2015
    available for Interim- and Project Management in Life Sciences: adding value and focus to development projects and programs; early and/or late stage. Available for interim- and project management in Life Sciences: adding value and focus to development projects and programs; early and/or late stage.

Past Experience

  • Co-founder, Managing Director

    December 2011 --- December 2015
    okklo Life Sciences was founded as a biopharmaceutical company developing novel therapeutic approaches using a cyclodextrin-based platform technology, with a focus on neglected and orphan diseases. responsible for company Strategy, positioning and funding. built a large network of collaborators (smes), patient organisations, potential investors, academia, eu consortia and other partners, resulting in several successful partnerships.

  • Research Manager

    October 2011 --- September 2013
    european patient organisation for neuromuscular disorders- providing an international platform for researchers and patient representatives to discuss the Research agenda in neuromuscular diseases. Managing Director of the organisation in baarn, the netherlands; responsible for Operations and financial results of the foundation. enmc has now hosted over 220 (global) meetings and has a network of some 2500 researchers and patient representatives that have been collaborating in and contributing to these workshops. european neuromuscular centre www.enmc.org

  • Director Clinical Research CNS (Anesthesia & Analgesia), MRL

    November 2009 --- September 2011
    group head, global Clinical research - responsible for global programs (us, eu and japan) including paediatrics within therapy area; - leading Clinical research group (science and Operations incl. kol interaction); - departmental mt Member

  • Director Clinical Research CNS (Anesthesia & Analgesia)

    November 2008 --- November 2009
    responsible for clinical part of submission and post-approval committment studies in usa, eu and japan (sugammadex, bridion) leading a team of Clinical research scientists. scientific lead for eu pediatric study program (6 studies) under pip. provide clinical input in poc-paradigms for analgesia development candidates.

  • Clinical Group Director, Global Clinical Development [The Netherlands]

    December 2004 --- November 2008
    responsible for Phase 2 and 3 Clinical Development projects (Anesthesia & analgesia) - leading a team of Research scientists and project managers. successfull submissions in eu, japan and usa and pediatric submissions (two pwr studies for FDA). part of schering-plough as of november 2007

  • Director Development Projects [The Netherlands]

    January 1999 --- November 2004
    global project Director, leading (late-stage) global development projects (pre-clinical, clinical, cmc, regulatory and Marketing) cross-functional and multi-cultural (global) teams, including Clinical Development teams. Therapeutic Areas: Anesthesia, analgesia/pain, oncology.

  • Head Analytical R&D [The Netherlands/France]

    January 1997 --- January 1999
    de-novo set-up and implementation of new this new department for intervet pharma R&D, including recruitment of new staff in france, Training programs and Laboratory design (angers, fr). managing introduction of LC-MS-ms into Veterinary bio-analytical studies.

  • Sr Project Manager [The Netherlands]

    September 1989 --- December 1996
    european CRO, providing bioanalytical and Clinical laboratory services. resposible for conduct of contracted studies for Pharmaceutical companies (including clients such as pfizer, fujisawa, roche), providing Project Management and scientific expertise. real-time pk support for international randomized, concentration-controlled trial for cellcept (mycophenolate mofetil) involving 6 transplantation centres.

  • QA Manager [Basel, Switzerland]

    August 1986 --- August 1989
    managing qc Lab for ergot-alkaloid products; qp

Personality

Self Assessment :
Analytical thinkingAttention to detailCollaborationCoordinationDependabilityDiligenceIndependenceOrganizationProblem solvingProactivityResult OrientedSelf-disciplineStrategic thinking

Knowledge

Self Assessment :
R&DAnalytical ChemistryAnalytical Method ValidationAnesthesiaBioanalysisBusiness DevelopmentChemistry, Manufacturing, and Controls (CMC)Clinical DevelopmentClinical researchCNSDrug DevelopmentFDAGood Clinical Practice (GCP)Good Laboratory Practice (GLP)International Project ManagementLaboratory ManagementMarketing Authorisation Application (MAA)New Drug Application (NDA)Operating RoomPharmaceuticalsPhases of clinical development (phase I to IV)Preclinical developmentProduct developmentProgram ManagementProject ManagementQuality AssuranceRegulatory submissionsSmall moleculesUrologyUnderstanding of regulatory guidelines
LinkedIn Assessment :
Clinical DevelopmentClinical trialsCROPharmaceutical IndustryDrug DevelopmentLifesciencesLife SciencesClinical researchGMPStrategyGlobal Drug DevelopmentBioanalysisAnalytical ChemistryDrug DeliveryFDAAnalytical Method ValidationGLPOrphan DrugsGlobal R&DPublication StrategyAdvisory BoardsRegulatory StrategyManagement Of International TeamsSituational LeadershipTeam LeadershipCollaborative R&DInterdisciplinary CollaborationPatient AdvocacyPublic Private PartnershipsComputer System ValidationSwiss GermanEarly-stage StartupsU.S. Food and Drug Administration (FDA)Non-profit Volunteering

Education

  • in from HollandBio BioBusiness Masterclass in 2012
  • in philosophy/theology from Tilburg University in 2011
  • PhD in Analytical Chemistry from University of Twente in 1985
  • PharmD in Pharmacy from Leiden University in 1981

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency
German
Professional Proficiency

Work Preferences

  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position :    60-80% FTE
    BrightOwl freelancer :    32 Hours per week :    80 Free Per Month(in coming months)
  • International:
    Yes

Area / Region

Breda, Netherlands

Others

Driving License
  • Yes

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