Steven Mortier is an ambitious professional who build up over 14 years expertise in pharma R&D in oncology, infectious diseases and neuroscience, including 11 years in clinical R&D. He has a background of Biotechnology from the Ghent University and obtained an executive MBA from the Antwerp Management School.
He is a calm, inclusive and results driven colleague with an open mind, and is eager to contribute and grow further his expertise in clinical R&D coordination and project management.
Clinical Program Management Leader Beerse, Belgium
Since December 2015
- Maintaining end-to-end oversight of clinical programs and its processes by taking an operational leadership role in integration of activities in a matrix organization
- Partnering with cross functional leads groups at the clinical program to assure end to end clinical trials oversight, and to identify and mitigate issues in order to maintain quality, timelines, resources and budget.
- Leading the clinical team with the clinical leaders to operationalise the strategy guided by the clinical leaders (including scenario planning and setting priorities) to ensure all activities are aligned with the overall goals and objectives.
- Including drug development programs for Alzheimer, Depression and Insomnia
Clinical Research Manager Beerse, Belgium
March 2011 --- November 2015
- Managing clinical trial activities of Phase 0, I and IIa worldwide, in collaboration with the cross-functional teams - in alignment with the clinical development plan.
- Provide guidance and leadership to various functional areas in the team, such as through leading clinical working group meetings.
- Collaborate with CRO’s, commercial and academic sites.
- Lead as finance representative for the CRM team.
- Lead the CRM team into smooth integration & alignment of Ph0 study timelines & resources.
- Selecting & guiding newcomers in the CRM team.
- Connecting many functional area leaders with the CRM team.
- Operational support in Discovery projects for HBV.
- Visualizing data translational medicine studies for management purposes (Spotfire)
- Some study examples: Exploratory non-interventional trials, HBV epitope mapping / ph I TQT– DDI – BA – SAD/MAD – hepatic/renal impaired - … / 2 Ph IIa trials with 3compound POC trial (incl PK / ePRO / Cognitive testing / microbiome analysis)
Scientist - Project Manager Brussels, Belgium
August 2002 --- June 2006
- Scientific assignments – project management, coordination, execution, analysis and reporting discovery studies in both in vitro (cell viability, mobility tracking, flow cytometry, etc) and in in vivo models (f.e. murine orthotopic & xenotopic immunosuppressed murine models).
- Scientist for both internal & CRO programs
- Project manager for all the programs in contract research for f.e. Astra-Zeneca, Beaufour, Lafon, etc.
Willingness to compromiseStrategic thinkingResult OrientedProblem solvingInterest in knowledgeInnovative thinkingIndependenceCommunicativeAnalytical thinking
BiotechnologieStrategic PlanningRisk ManagementProject ManagementProject CoordinationProblem SolvingPhase IPhase IIIPhase IIPharmaceutical ResearchPharmaceutical IndustryPharmaceutical DevelopmentPatient recruitmentOutlookOperations ManagementOncology Clinical ResearchNeuroscienceMS ProjectMolecular geneticsMicrosoft ProjectMicrosoft OfficeMicrosoft PowerpointMitigationMicrosoft WordMicrosoft ExcelInternational Project ManagementInfectious diseasesIn VivoGood Clinical Practice (GCP)Ethics submission and approval processEnglishEnglishEfficacy trialsEarly development stageDrug DevelopmentCommunication SkillsCoachingClinical trialsClinical trial managementClinical trial budgetingClinical researchClinical operationsClinical DevelopmentClinical monitoringCancer ResearchBusiness PlanningBudget ProcessBudget ManagementBiotechnologySafety trialsProject Planning
Skills and Expertise
Analytical skills Interact with physiciansAlzheimerAssess site feasibilityassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assist with proceduresAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companybudgeting of R&D activitiesBuild trial master file (TMF)CoachCollaborate with project teamcontrol different protocol versions and other essential documentsCoordinate projectscoordinating research projectsDesign clinical presentationDesign studiesDesign trial master file (TMF)Develop business planDevelop study budgetEvaluate protocolsFinancial administrationFinancial reportsInitiate clinical trials Interact with KOLLiaise with doctorsManage budgetsManage projects resourcesManage study budgetManage trial master file (TMF)Organise meetingsproject managementR&DReview protocolsReview medical reportsReview monitoring reportsReview study protocolsSelect investigatorsSolve problemsSite managementSet up a clinical studySelect sitesReview informed consent processUnderstand protocolsTranslate customer needs into analytical study proposal/protocolStudy execution planPlanning clinical studiesNetwork
Advanced Master in Business Administration (MBA) from Antwerp Management School (AMS) in 2014
Advanced Master in Laboratory Animal Science (Category C) from Gent University in 2005
Master in Biotechnology from Gent University in 2001
Training and Certification
Post Graduate Course - introduction in management in 2009 Training
Post Graduate Course - Principles in Chemotherapy in 2008 Certification
Post Graduate Course - Non-Small-Cell-Lung-Cancer in 2007 Certification
Expert has 5 publications (Will be avalible with full profile)