CurriculumVitae – Nanna Keeling (MSc Dip MPharm)
Personal Details
Name: NannaKeeling
Address:25 BrunswickTerrace,BN31HJ, H...
research programs aim to understandthe diseaseprocessanddevelopnovel andaffordable
therapiesinordertointervene topreventlo...
● Responsible forteam’sactivitiestosupportmarketingandsalesactivitiesbyproviding
scientific/medical information,enquiryhan...
● Accountable forcommunicationof keystrategicmaterialtobothinternal seniorR&D
stakeholdersanddecisionmakers,suchasthe Port...
Global Clinical Study Leader,Nexium® & Crestor®
Sept 2000-May 2006
AstraZeneca R&D Mölndal
Keyareasof responsibility;
● Gl...
● Responsible forensuringthatmedical enquirieswere handledinaccordance withthe PIPA
guidelines
● Maintainand developMedica...
Schmidt S, Keeling N, Eklund S, Naucler E, Labenz J. A comparison of esomeprazole 40 mg once-daily and
pantoprazole40 mg o...
Clinical Information
Science Director
member of the
Clinical project Team
COPD (S&T) IIa 87 10 Bulgaria, Germany,
Hungary,...
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Nanna Keeling CV 2016

Published on: Mar 3, 2016
Source: www.slideshare.net


Transcripts - Nanna Keeling CV 2016

  • 1. CurriculumVitae – Nanna Keeling (MSc Dip MPharm) Personal Details Name: NannaKeeling Address:25 BrunswickTerrace,BN31HJ, Hove,UK Telephone: +44 1273 905458 Mobile:+44 7478 800865 Date of Birth: January8th 1968 LinkedIn:http://se.linkedin.com/pub/nanna-keeling/1/917/746 Career summary A pharmacistbytraining,Igraduatedfrom UppsalaUniversity in1995. Overthe past 20 yearsI have beenworkinginvariousdisciplinesandtherapeuticareas of the Pharmaceutical industry. The key feature of mycareer has beenprojectmanagementof cross-functionalcomplexglobal clinical & drug developmentprograms,ensuringtheirstrategicalignmentwithcompany’score objectivesand theirdeliverytotime, budgetandquality. Myexperience stretchesfromdesign,set-upandleading of earlyphase and largerglobal late phase clinical studiestoworkingcloselywithFunctional Heads on implementationof results. Ihave extensiveknowledge of GCP/ICHguidelinesandFDA/EMEA regulationsandbeeninvolvedinregulatorysubmissions. Leadershipof global &cross-functional teamsand projects,withreal passionformyteamsandcustomers has beenalwaysbeen key feature of mycareer.I also have experience fromworkingwithexternal partnersandCROs,KOLs, and scientificAd-boardsandbeenresponsible forbudget,resources (incl.linemanagementof staff) andriskand opportunitymanagementof multimilliondollarprojects. Iampassionate about highqualityandethical deliveryof soundscientific/clinical datatosupportthe strategiesfor developinglifesavingdrugsandproducts. Education & Qualifications Master of Science inPharmacy, UppsalaUniversity,Sweden Jan.1990 - June 1995 Postgraduate studies,Diplomain Pharmacy, UppsalaUniversity Sept1995 - Aug.1996 EU-PharmacyPractice Career Details Global Clinical Lead November2015 – Ongoing Thrombosis ResearchInstitute,London Manresa Road, London SW3 6LR, UK Key areasof responsibility: Oversightandmanagementof the clinical operationsdepartmentatTRI London. Internationally renownedforpioneering,multi-disciplinaryresearch,the ThrombosisResearchInstitute is dedicatedtothe studyof thrombosisandrelateddisorders.The TRIisa charityand a purely scientificresearchinstitute whichworksindependentlyasanacademicinstitution. The Institutes’
  • 2. research programs aim to understandthe diseaseprocessanddevelopnovel andaffordable therapiesinordertointervene topreventlongtermdisablementandearlydeath. Asglobal clinical leadI workalongside the COOandmanage the Global & Regional ProjectManagershere atthe institute andprovide globalstrategicleadershipandoversightforthe on-goingandplannedclinical work.For furtherinformationaboutthe currentandpastachievementsof the TRI,please goto www.TRI-london.ac.uk Freelance Medical Writer& Editor January 2015 – November2015 FPEC UK,BN1 5BF, Brighton,UK Keyareasof responsibility: As a medical writerIcommunicate scientificresearchtoa professional orlayaudience,eitherfor journals,promotionalbrochuresandwebsites.Myworkhas an elementof editingorbroader communicationsresponsibilitiesinadditiontoresearchingandwriting. Thisrole isaproject managementrole withinthe scientificpublicationsarena. Global Medical Marketing& Evidence Director March 2013 – October 2014 Mölnlycke HealthCare AB, Gothenburg,Sweden Keyareasof responsibility; ● Headof Medical Marketing (Medical Affairs) &Evidence divisiongloballyforMölnlycke HealthCare,includingline management of the staff (6directreports) andown budget ● Providingleadershiptothe managementteamforthe Medical MarketingInformation supportfor all products& technologiesglobally ● Responsible forthe creationanddevelopmentof abrand new operatingmodel andrelated processes (SOPs) forthe managementof scientificevidence atMolnlycke HealthCare ● Accountable forthe implementationof the new operatingmodel globally ● Responsible forsupportingstrategiesandtacticswhichdrive the developmentof evidence; including,butnotlimitedtolaband benchtesting,animal studiesandclinical andfinancial studiesinalignmentwithMölnlyckeHealthCare'sWoundCare Division’sbusinessneeds ● Directlyinvolvedinclinical studyprotocol development ● Monitor/collate performance indicatorsforthe Medical Marketing&Evidence Team ● Chairand headof the Clinical andEconomicEvidence Committee(CEEC) ● Coordinate anddirectworkloadforthe Medical Marketing& Evidence Team ● Accountable fortimely,accurate review andapproval of promotionalmaterialsin accordance withthe relevantCodesof Practice bythe Medical Marketing & Evidence Team ● Accountable forthe developmentandmaintenanceof Medical Marketing andmedical information’s SOPsandguidelines ● Provisionof scientificandtechnical supportandadvice toidentifyandsupportbusiness developmentopportunities/productlaunchesandcontribute tothe developmentof marketingcampaigns ● Representationof medical &scientificinformationinmultiplestrategicteamsand Core TherapeuticTeams ● Responsible forkeepingup-to-datewithemergingtechnology/businessrequirementsand the potential impactonthe business andreportingbacktothe board
  • 3. ● Responsible forteam’sactivitiestosupportmarketingandsalesactivitiesbyproviding scientific/medical information,enquiryhandling,clinical paperprovisionandtraining ● Responsible andaccountable forthe supportmarketingteamswithuptodate information on products,disease areasandcompetitoractivity ● Representthe Medical Marketing&Evidence divisionbothinternallyandexternally ● Responsible forthe coordinationandprovisionof traininginthe fieldof medical & scientificinformationandevidence management SeniorManagementConsultant October 2011 – Feb2013 Wenell MangamentAB,GothenburgSweden Keyareasof responsibility;  Providingmanagementconsultancytopharma/ biotech clientsonbehalf of the firm  Reviewandassessmentof keystrategicprojectsonbehalf of the clientandidentifyareasof riskand slippage (includingproposalsforimprovementandcontingencyplanning)and generatingreports tothateffectforseniormanagementanddecisionmakingbodies  Providinginput andadvice asa consultantintoprogramplanningeffortstogetherwiththe supportingfunctions,client’sprojectmanagers andvendorstocreate operational plans  Supportingandhelpdrive the coordinationof governance approvalsforthe keyproject deliverables Clinical InformationScience Director, Cardiovascular & Respiratory & InflammationTherapy Area Aug 2008-Sept 2011 AstraZeneca R&D Molndal,Sweden Keyareasof responsibility; ● SeniorR&D memberwithinthe ClinicalDevelopmentdivisionatAstraZeneca ● Core memberof the Clinical ProjectTeam,responsible forthe projectmanagementand deliveryof the clinicalinformationscience componentsof one ormultipledrugproject withinaspecificTherapeuticArea(TA) ● Leaderof a cross-functionalteamof multiple seniorleadersincl. biostatistics (Global productStatistician),datamanagement(DataManagementProjectLeader), Programming(Global ProgrammingLeader),medical authoring(Global Medical Writer), scientificpublications(Global PublicationManager),clinical publication(GlobalClinical PublicationLeader),regulatoryaffairs(RegulatoryAffairsManager),healtheconomics (Global HEOR lead) ● Accountable fordeliveryof all clinical information components fromstarttofinishindrug developmentprojects, includingprotocol development &signoff, the scientific interpretation,reportingandpublishingof the data/informationforregulatorysubmissions and scientificpublications ● Workingcross-functionallyandglobally withkeystakeholderssuchasRegulatoryAffairs, Pharmacovigilance,Marketingandheadof TA to ensure projectswere continuouslyaligned to core strategicobjectivesandsubmissionsandapproval deadlineswere kept
  • 4. ● Accountable forcommunicationof keystrategicmaterialtobothinternal seniorR&D stakeholdersanddecisionmakers,suchasthe PortfolioReview Boardandexternallyat scientificmeetings ● As the projectmanagerforInformation Sciencesinthe TA;responsibleforestablishing, communicatingandexecuting plansinordertoachieve projectgoals including ● Accountable forthe on-time,accurate andqualityassureddeliveryof all the clinical componentsof ourassigneddrugprojects includingidentifyinganddrivingprojectand resource prioritiesthatalignwiththe businessobjectives Global ProjectManager, Symbicort® Global Product Team May 2006-July 2008 AstraZeneca R&D Lund, Sweden Keyareasof responsibility: ● SeniorR&D role withinthe DevelopmentProjectsorganisationwithcross-functional project managementaccountability,reportingdirectlytothe VPGlobal ProductDirector(VPGPD). ● Memberof the Global ProductTeam(GPT) ● Responsible forthe coordinationof the GPT activities,suchasmeetings,minutesand disseminationof actionsanddecisionstofunctional deliveryteams ● Responsible forprovidinglinemanagement teamwithinputincross-functional delivery team’sperformance andactive memberof the appraisal team ● Responsible forprovidingsubjectmatterexpertinputandpart of final draftapproval processof clinical studyprotocols ● As GPMresponsibleforall PMactivitieswithinthe GPTincluding; - Riskmanagementthroughproactivelyidentifyingpotentialissuesor obstaclesand developingsolutionsorcontingencypwithappropriate follow upprocessestill resolution - Managementof projectstatusreportsboth forplannedorad-hocitems - Responsible forensuringthe involvementof all appropriate regional teams,functions and divisions(includingexternal partnersorservice providers) inrelevant communications,decisionsandworkinggroups –statusupdateson a weeklybasisto the GPT - Responsible foridentifyinganddrivingprojectandresource prioritiesthatalign with the businessobjectives - Responsible forgeneratingglobal communicationplansonbehalf of the GPTandthe disseminationof the plantoregional,functional anddivisional teams(incl.external partners) – Ensuringclearcommunicationandplanningacrossthe project(Symbicort) ● Involvedandcontributedto all decisionspertainingtothe successful developmentandLife Cycle Managementactivitiesforthe productandthe leadershipof multiple DeliveryTeams (DT) – I.e. US NDA Submissionof Symbicort, JapanRegulatorysubmissionTeam, EU& RoW DT for the developmentof newstrategiesforfurthermarketaccess (incl the Rapihaler Project)
  • 5. Global Clinical Study Leader,Nexium® & Crestor® Sept 2000-May 2006 AstraZeneca R&D Mölndal Keyareasof responsibility; ● Global clinical programleadandresponsible projectmanagerforthe clinical operations aspectsof the studies ● Accountable andresponsible forthe deliveryof clinical studiesfromearlytolate phase of developmentandmultipletherapyareasaccordingtoGCP and internal companystandards and SOPs ● Responsible andaccountable fordevelopingclinical study protocolsandfinal approval ● Projectmanagementof the operationalplansensuringstudy delivery totime,budgetand quality ● Identifyingandmanagingriskswithinthe projectsandworkingcollaborativelytodeliver solidsolutionsorcontingencyplans ● Responsible forcommunicationplansforthe project,globally ● Responsible forprojectplanninganddeliveryof monitorsmeetings,investigatormeetings, endof studymeetings ● Representingthe clinical studyteamandprojectinternallyandexternallyona global scale ● Workingcross-functionallyandcross-regionallytoensure projecttimelinesanddeliverables were kept ● Commissioningauditsof internal projectteamandinvestigatorssitesandworkingclosely withthe internal QA teamto enable suchaudits,includingreportingbacktoHead of Clinical TA SeniorDrug/Device SafetyScientist,Diabetes& Neurology March 1998 – Aug. 2000 Eli Lilly& CompanyErl WoodManor, Windlesham,SurreyGU20 6PH, UK Keyareasof responsibility;  Pharmacovigilancescientistresponsible foranalysingandreportingof safetyreports  Responsible forprocessimprovementandSOPdevelopmentwithinthe PV-departmenton a global scale SeniorMedical Information Executive Dec. 1996 – Feb.1998 Warner Lambert Parke Davis, Eastleigh,Hants, SO53 3ZQ, UK Keyareasof responsibility; ● Medical Informationexecutive providingscientificandmedical supportfor all productsin the UK. ● Deputyto the Headof Medical Informationdepartment asrequired ● Monitoringandcollationof performance indicatorsforthe Medical InformationTeam – auditthe Medical EnquiryDatabase and setstandardsas and whenrequired.
  • 6. ● Responsible forensuringthatmedical enquirieswere handledinaccordance withthe PIPA guidelines ● Maintainand developMedical InformationITandlibraryresources ● Timely,accurate reviewandapproval of promotionalmaterialsinaccordance withthe relevantCodesof Practice bythe Medical InformationTeam ● KeyContributortothe developmentandmaintenance of Medical InformationBOPsand guidelines ● Part of team which operatedandprovidedsupportforthe 24 hour medical on-call service ● Preparingstandardletters,productsummaries/reviews,formularypacks. ● Responsible forthe supporttomarketingandsalesactivitiesbyprovidingscientific/medical information,enquiryhandling,clinical paperprovisionandtraining ● Supportmarketingteamswithupto date informationonproducts,disease areasand competitoractivity ● Responsible forproductinformationtraining Scientific Publications Labenz J, Armstrong D, Lauritsen K, Katelaris P,SchmidtS, Schütze K, Wallner G, PreiksaitisH, Keeling N, Nauclér E, Eklund S, Juergens H. A randomized comparativestudy of esomeprazole 40 mg versus pantoprazole40 mg for healingerosiveoesophagitis:the EXPO study. Alimentary Pharmacology & Therapeutics 2005;21(6):739-46 Bayerdörffer E, Sipponen P, Bigard M, Weiss W,Mearin F, Rodrigo L, Dominguez Muñoz J, GrundlingH, Nauclér E, Svedberg L, Keeling N, Eklund S. Esomeprazole 20 mg continuous versus on demand treatment of patients with endoscopy-negative reflux disease(ENRD). Gut 2004;53(Suppl VI):A106, Abs MON-G-168 Bayerdörffer E, Sipponen P, Nauclér E, Svedberg LE, KeelingN, Eklund S. Esomeprazole 20 mg on-demand compared to long-term therapy in patients with non-erosive esophageal reflux disease(NERD). Zeitschriftfür Gastroenterologie 2004;42(8):Abs P055. Labenz J, KeelingN, Eklund S, Nauclér E. A comparison of esomeprazole 40 mg once-daily and pantoprazole 40 mg once-daily for the healingof erosiveesophagitis.Can J Gastroenterol 2004;vol 18 Suppl A: abstract147 Labenz J, KeelingN, Eklund S, Nauclér E. Treatment of erosivereflux esophagitis with esomeprazole and pantoprazole: results froma randomized, double-blind multicenter study (EXPO). Zeitschriftfür Gastroenterologie 2004;42(8):Abs V007 Labenz J, KeelingN, Eklund S. A comparison of esomeprazole 40 mg once-daily and pantoprazole40 mg once- daily for the healingof reflux oesophagitis.Gut 2003; 52 (Suppl VI) A241 Labenz J, Naucler E, Keeling N, Eklund S. Esomeprazole 40 mg heals significantly more Helicobacter pylori - negative erosiveesophagitis patients than pantoprazole40 mg. Gastroenterology 2004;126(4 Suppl 2):A-338, Abs M1458.
  • 7. Schmidt S, Keeling N, Eklund S, Naucler E, Labenz J. A comparison of esomeprazole 40 mg once-daily and pantoprazole40 mg once-daily for the healingof erosiveesophagitis. SAMJ South African Medical Journal 2004;94(8):688. Labenz J, Armstrong D, Lauritsen K, Katelaris P,SchmidtS, Schütze K, Wallner G, Juergens H, Preiksaitis H, Keeling N, Nauclér E, Adler J, Eklund S. Esomeprazole 20 mg versus pantoprazole20 mg for maintenance therapy of healed erosiveesophagitis:results fromthe EXPO study. in press 2005 Alimentary Pharmacology and Therapeutics Membershipof Professional Bodies Memberof: The Royal Pharmaceutical Societyof GreatBritain,andmemberof AIOPI&Institute of Clinical Research.The SwedishPharmaceutical Associationandthe SwedishPharmacistAssociation, Registered&licensedpharmacistwiththe SwedishNational Boardof Health. References Provided upon request. Interests andHobbies I love spendingqualitytime withmyfamily.Iamalsoa fitness&travel enthusiast. List of Clinical Study Work – 2000 - 2011 Role on Study (e.g. CRA, CPM etc.) Indication Phase No. of patients No. of sites Countries involved Services involved (e.g. full service or just clinical) Stages of study involved (e.g. set u etc.) Clinical Study/ programme Leader Erosive oesophagiti s IV 3000 <250 Australia, Brazil, Argentina, Poland, Slovakia, Romania, Hungary, UK, Germany, Russia, Bulgaria, Switzerland, Sweden, Denmark, Greece, France, Spain, Canada R&D funded trial, as study / program lead all services were managed All stages from start (CSP w Clinical Study/ programme Leader endoscopy- negative reflux disease (ENRD) IIIb 450 56 Germany, Poland, UK, Switzerland, Denmark, Hungary R&D funded trial, as study / programme lead all services were managed All stages from start (CSP w Clinical Study/ programme Leader endoscopy- negative reflux disease (ENRD) IIIa 250 30 Germany, Poland, Switzerland, Denmark, Hungary R&D funded trial, as study / programme lead all services were managed All stages from start (CSP w Clinical Study/ programme Leader Heart failure IIIb/IV 5011 371 19 European countries, Russia, and South Africa R&D funded trial, as study / programme lead all services were managed All stages from start (CSP w
  • 8. Clinical Information Science Director member of the Clinical project Team COPD (S&T) IIa 87 10 Bulgaria, Germany, Hungary, Ukraine R&D funded, outsourced to CRO for conduct. Involved in study design concept, d handover to CRO, collaboration wi progression and taking over from i Clinical Information Science Director member of the Clinical project Team COPD (Bronchiect asis) IIb 52 8 UK, Czech Republic, Poland. R&D funded, outsourced to CRO for conduct. Involved in study design concept, d handover to CRO, collaboration wi progression and taking over from i Clinical Information Science Director member of the Clinical project Team COPD I (JS AD/ JMAD ) 63 1 UK (Japanese subjects recruited in UK) R&D funded, outsourced to CRO for conduct Involved in study design concept, drawing up agre and handover to CRO, collaboration with CRO thro study progression and taking over from interpreta stage Clinical Information Science Director member of the Clinical project Team COPD I (ADM E) 6 1 UK R&D funded, in-house study Overseeing all aspects from start to finish – from CSP to CSR & Publication Clinical Information Science Director member of the Clinical project Team COPD (S&T) IIa 63 4 Bulgaria, Slovakia. R&D funded, outsourced to CRO for conduct Involved in study design concept, drawing up agre CRO, collaboration with CRO throughout study pro from interpretation stage Clinical Information Science Director member of the Clinical project Team COPD IIb 43 3 Germany R&D funded, outsourced to CRO for conduct Involved in study design concept, drawing up agre CRO, collaboration with CRO throughout study pro from interpretation stage Clinical Information Science Director member of the Clinical project Team Oral Anti- Arrhythmia IIa 125 12 CEE, Germany, UK R&D funded trial, In- house study management Involved in all aspects from start to finish, CSP to CSR & Publication Clinical Information Science Director member of the Clinical project Team Oral Anti- Arrhythmia I 75 1 Japan R&D funded trial, In- house study management Involved in all aspects from start to finish, , CSP to CSR & Publication Clinical Information Science Director member of the Clinical project Team Oral Anti- Arrhythmia IIb 112 7 CEE, Germany, UK, Switzerland R&D funded trial, In- house study management Involved all aspects from start to finish, , CSP to CS & Publication

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