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Summary

20 years of experience in global Pharmaceutical/biotech and 'start-up' industry: Leadership and program and portfolio management of Medicine and Medical Device development. Therapeutic Areas: Infectious diseases, Dermatology, Animal Health, CNS, gi, cystic fibrosis experience in: managing and leading complex programs, leading multidisciplinary teams, proving strategic insights, program / portfolio management, personnel / Line Management, e2e Medicine/Drug Development & Commercialization, Medical Device development and market readiness, Medicine submissions and registrations in global markets, launches, creating operational / process excellence, e2e global Supply Chain Planning, business oriented Leader in an international and complex matrix-structured organization: - lead of R&D team (product related) - lead of Program Management team - line manager of pm professionals - lead of process excellence initiatives - alliance management: develop, maintain and lead strategic partnerships with companies - portfolio management to support business unit Leader experienced in setting long-term strategic product direction + implementation in a realistic and integrated operational plan with clear assumptions (schedule, budget, resources, risk, kpi). resulting in: - 3 Medicine submissions and registrations - 16 launches in eu markets (reimbursed/non-reimbursed) in 1 year hands on Pharmaceutical experience: chem-pharm development, pmo, Clinical operations, global Supply Chain hands on Medical Device development experience hands on disease management program experience. trained in european Regulatory Affairs, pmp, Market access, vlerick business school, kuleuven (phd in Sciences), sroi dynamic, result driven problemsolver, customer focused, great communicator, challenges status quo, team player Leader of diversity team

Experiences

Current Experience

  • Expert


    Since June 2016
    assessment and evaluation of funding proposals Assessment and Evaluation of funding proposals

  • Consultant and Business Owner


    Since October 2013
    pi m Consulting bvba challenges the status quo in life science industry (Pharmaceutical, Biotechnology, start up) - medicines or Medical Devices development. Consulting services include, but are not limited to: program Leadership portfolio, program and Project Management strategic direction, Strategic Planning organizational management Change Management process optimalizations alliance management management of multi-disciplinary Medicine / Medical Device development projects: - R&D (early stage, late stage) - registration and approval process - launches - post-Marketing (supply chain, Market access, commercial) - life cycle management - in different disease areas (CNS, gi, Infectious diseases, vetrinary Applications, Dermatology, cystic fibrosis) background: - master in Bioscience engineering and phd in physical Chemistry - kuleuven - vlerick business school - ghent/leuven - Project Management professional certified - eu Regulatory Affairs certified - social return on investment (sroi) methodology hands on experience in: - program / portfolio management - global Strategic Planning - cross-functional Project Planning - Clinical operations - cmc development / Manufacturing - regulatory and Quality System implementation (ISO 13485) - Medical Devices - alliance management - budget management - Supply Chain Management (end to end planning) - defining outcomes (logic model, theory of change model and sroi) Pi M Consulting BVBA challenges the status quo in life science industry (Pharmaceutical, Biotechnology, Start Up) - Medicines or Medical Devices development. Consulting services include, but are not limited to: Program leadership Portfolio, Program and Project management Strategic direction, Strategic planning Organizational Management Change Management Process optimalizations Alliance Management Management of multi-disciplinary medicine / medical device development projects: - R&D (early stage, late stage) - Registration and approval process - Launches - Post-marketing (Supply Chain, Market Access, Commercial) - Life cycle management - in different disease areas (CNS, GI, Infectious Diseases, Vetrinary applications, Dermatology, Cystic Fibrosis) Background: - Master in BioScience Engineering and PhD in Physical Chemistry - KULeuven - Vlerick Business School - Ghent/Leuven - Project Management Professional certified - EU Regulatory Affairs certified - Social Return on Investment (SROI) methodology Hands on experience in: - Program / Portfolio Management - Global Strategic Planning - Cross-functional Project Planning - Clinical Operations - CMC development / manufacturing - Regulatory and Quality System implementation (ISO 13485) - medical devices - Alliance Management - Budget Management - Supply Chain Management (End to End Planning) - Defining outcomes (Logic Model, Theory of Change Model and SROI)

  • Boardmember Senate Faculty Bio-Engineering


    Since June 2013
    provide advice to the faculty Bioscience engineering at the kuleuven, representing the Pharmaceutical Industry. Provide advice to the Faculty Bioscience Engineering at the KULeuven, representing the Pharmaceutical Industry.

Past Experience

  • Program Management Leader Disease Management Programs

    September 2014 --- January 2017
    responsibilities: program and portfolio management of disease management programs in support of patients and Health Care providers in countries with limited resources. defining outcomes, value (impact) of programs by using logic model and social return of investment methodology (sroi).

  • Program Manager Research and Early Development - Cystic Fibrosis

    September 2015 --- May 2016
    portfolio of early stage compounds in development

  • Management TheraSolve - Program Management / Clinical / Regulatory / Quality

    October 2013 --- March 2016
    Medical Device R&D roadmap to market readiness, Clinical lead, regulatory lead, iso13485 Quality System implementation lead, Business Development, governmental funding projects, partnerships

  • End to End Global Supply Chain Planning Lead

    February 2014 --- November 2014
    consultancy project - drive and deliver improvements in global Supply Chain project processes and services to introduce Supply Chain efficiencies: supply variability minimization, lead time reduction, inventory optimization, management of production requirements at global sites.

  • Director, Global Strategic Planning and Program Management

    August 2011 --- September 2013
    responsibilities: - gi business unit strategic pm Partner - optimisation of gi portfolio (p&l) - define compound Strategy (R&D, commercial, Market access and Supply Chain) and translate into an integrated and aligned operational plan: activities, resources, Budgets, kpis. - lead of development team - R&D development activities and budget - alliance management with j&j - s&op experience - co-lead of the new market introduction teams - lead in Business Planning processes and business case developments - R&D budget management and p&l oversight - cross-functional problem resolution, Risk Management, Change Management - Communication to management results: - 16 launches in 2012 - received gsp&pm business excellence award for the year 2012 added skills: lead of R&D product team expertise beyond R&D such as commercialisation, Market access, Supply Chain, alliance management, portfolio management, product launches.

  • Director, Program Management Organization (Program Management Leader)

    September 2004 --- August 2011
    responsibilities: - R&D Program Management lead - set Product Development Strategy with compound development team and as Operations Leader ensure flawless implementation into a realistic, integrated and executable operational plan with schedules, Budgets/resources, including Risk Management - Business Planning - lead of cross-functional Program Management team - alliance management with gilead Sciences - lead of global process excellence initiatives: optimised modus operandi between tibotec and j&j organisations (R&D, commercial, Marketing, medical affairs, Finance), during integration results: - world-wide submissions and registrations of nce hiv compound - world-wide submissions and registrations of line extension in co-development with gilead (fixed dose combination tablet) - on target management of R&D operational activities, incl. team budget (average budget of + $50m per year). - standard of Leadership awards obtained skills: cross functional team Leadership, Program Management, global submissions /registrations, alliance management, process excellence

  • Director, Program Management Office, functional head

    January 2009 --- June 2011
    responsibilities: - functional head of different groups of Project Management professionals within pmo department: - setting strategic direction, representing these groups in staff meetings, general support and workload management, Talent Management, performance appraisals - obtained responsibilities over different groups with increasing business impact - co-lead of the pml community of practice (+40 early and late development peers across different Therapeutic Areas), installed pml Career ladder and key competencies per level - mentor and Coach of peers results: promotion of 2 employees obtained skills: supervising, Coaching, mentoring and Training

  • Assistant and Associate Director, Clinical Operations Logistics

    June 2001 --- September 2004
    responsibilities: - 3-year expatriat program: different roles with increasing responsibilities - instrumental in establishing a new group clinical Planning in us - CNS results: global line extension submission and registration (controlled release Formulation) obtained skills: Clinical operations, submission, cultural awareness and global perspective

  • Assistant Manager and Manager, Project Management - Planning

    January 2000 --- June 2001
    - responsible for R&D Planning - Dermatology, vetrinary, material preservation portfolio at j&j

  • Chemical Development Engineer

    May 1996 --- January 1999
    responsibilities: - api chemical synthesis: improved chemical syntheses in Lab environment introducing significant savings, in line with safety, environmental and regulation requirements (GMP) - upscaling of chemical processes from Lab to pilot scale to production scale - trouble shooting out of spec batches in chemical production - developed service level agreements between chemical development, production and Engineering - technology improvements: team Leader for separation process services - introduced lasentec (crystallization probe) in chemical development and production (awarded with dr. paul janssen award); trained staff on crystallization processes

Knowledge

LinkedIn Assessment :
Program ManagementPharmaceutical IndustryCross-functional team leadershipLine ManagementChemical EngineeringOperational Risk ManagementBusiness PlanningCompound StrategyGlobal ManagementAnalytical SkillsProblem SolvingInternal CommunicationsStrategic AlliancesRegulatory submissionsRegistrationmanagementBiotechnologieStratClinical trialsLevenswetenschappen

Education

  • certified in Business Administration and Management, General from Vlerick Middle Management Program in 2009
  • Project Management Professional (PMP) in from Certified in Project Management in 2003
  • Certification by examination in Regulatory from European Regulatory Affairs Course in 2001
  • PhD in Physical Chemistry from Doctor’s Degree in Engineering in 1997
  • Master of Engineering (M.Eng.) in Chemistry and Food technology from Master in Bio-Engineering in 1993
  • in from Music and Dans academie in 1988

Area / Region

Vosselaar, Belgium

Others

Driving License
  • No

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