Andreas Ayukebi verfügbar

Andreas Ayukebi

Associate PD Medical Director_ (Pediatric - Hematology/Oncology), Program Leader/Research Physician - Gastroenterology & Hepatology, Global Clinical Trial Head

verfügbar
Profilbild von Andreas Ayukebi Associate PD Medical Director_ (Pediatric - Hematology/Oncology), Program Leader/Research Physician - Gastroenterology & Hepatology, Global Clinical Trial Head aus Haan
  • 42781 Haan Freelancer in
  • Abschluss: nicht angegeben
  • Stunden-/Tagessatz: nicht angegeben
  • Sprachkenntnisse: deutsch (Muttersprache) | englisch (gut) | französisch (gut)
  • Letztes Update: 03.12.2019
SCHLAGWORTE
SKILLS
HIV, Oncology, Pediatrics, Hemophilia, Endocrine, Metabolic, Rheumatoid Arthritis, Diabetes Melitus, Mental Health, CNS, Cardiovascular, Respiratory, Gastrointestinal, C-IBS, Immunology, Dermatology, Gynecology, Musculoskeletal, Hepatology, Digestive System, SAP, CDP, GCP, DB systems, REDCap, VALDIG, CRF, IMPD, data management, DB, Windows 2000/ XP, MS Word, Excel, PowerPoint, MS-Project, CoralDraw, Documentation System
PROJEKTHISTORIE
  • 12/1996 - bis jetzt

    • Roche
    • >10.000 Mitarbeiter
    • Pharma und Medizintechnik
  • Associate Medical Director

  • 04/2016 - 02/2019

    • F. Hoffmann-La Roche Ltd
  • Associate PD Medical Director_ (Pediatric - Hematology/Oncology)
  • * Provides Medical leadership of all for utilization management, cost containment, and medical quality improvement activities.
    * Performs medical review activities pertaining to developing and executing (Phase I/II - III) clinical strategy and dev. Plans.
    * Report study program updates (clinical, scientific data, regulatory submissions, financial, achievement & risk and mitigation
    plan) to Chief Medical Officer and Sr. Vice President of Oncology
    * Provides competitive intelligence and market/industry influence and/or implication to assigned therapy
    * Developing clinical science information`s for inclusion into annual and strategic Life Cycle Management Plan (LCMP) and
    Integrated Development Commercialization Plan (IDCP)
    * Working with internal and external healthcare partners, stakeholders, PIs, Clinical Scientists, KOLs, regulatory, business
    to develop/maintain measurement indicators
    * Working with CST in providing clinical science input and guidance on early development studies
    * Lead and ensure that all Clinical Research strategy and clinical Pans within the responsibility Development Groups are
    developed and managed in terms of........
    * Provide overall management of clinical trials, early development studies, review Phase I-III protocols,..as assigned
    * Developing and review PV documents, statistic analysis plan (SAP), study reports, and other regulatory documents, clinical
    strategic plan (CSP), and development plans (CDP)
    * Leads and support clinical partners in transitioning of indications into Phase III or publication studies. (Developed and
    Reviewed Phase II/III protocols and/or provided CD input)
    * Developing product safety profile, clinical sections of IB, , and others
    * Conduct site and CRO selection, investigator and patient recruitment, point-of-contact for CROs
    * Performs medical monitoring; conducted ongoing review of medical/safety data's
    * Update and develop PSURs, ASR, DSUR, and reviewed medical writing
    * Measures and monitor study progress against objectives; provided mitigation plans
    * Perform medical monitoring, medical data review, safety data review, RMP, and chair DE Meetings with PIs and team
    * Developing health authorities submission documents, Pediatric Investigational Plans (PIP), Post-Marketing commitment
    (PMC), documents to FDA
    * Developing communications strategies to support existing studies. Includes KOL interactions, advisory boards, medical meetings,
    Congresses, publications and other materials
    * Provides input for regulatory submissions and processes; developed label & packaging language.

  • 09/2013 - 04/2016

    • Inselspital / University Clinic
  • Program Leader/Research Physician - Gastroenterology & Hepatology
  • * Senior Physician & Sub-Investigator- Clinical Research Projects (Research Leader)
    * Drafting and reviewing Clinical Study Protocol, ICF and Pat. Info's
    * Provides medical/operational leadership of all management of studies through phases II to IV studies, (start-up, to close-out)
    in accordance with ICH/GCP and SOP's
    * Developing SOPs, working documents processes, DB systems, REDCap and VALDIG.
    * Providing intervention and expertise on IIT, Observational, Epidemiological studies
    * Perform Sponsor feasibility (country and site selection), identify potential investigators
    * Perform medical/operational data review; analyse/interpret data`s for final report, publications and presentations.
    * Review and prepare study specific templates and documents, for handbooks, Protocol, PIS, ICF, CRF &
    completion guidelines
    * Provids GCP-Training and mentore new physicians and study team members, CRAs, Study nurse
    * Prepare and manage resources and budget(s) plan, EC Submissions, Regulatory Affairs (Swiss medics, local EC)
    * Develop and executed Publication Planning Strategy

  • 12/2009 - 08/2013

    • Novartis Pharma AG
  • Global Clinical Trial Head
  • Novartis Pharma AG, Basel, (Oncology Translational Medicine Unit)

    * Leads and manage Global Clinical Phase I,1b, and II trials; review and signing-off clinical documents related to
    clinical studies within area of responsibility
    * Provide directions and leadership to Global Operation and Medical Monitoring of assigned clinical trials and expertise to
    Global clinical team to ensure all cross-functional activities outlined in the clinical development plan
    * Line-managed (some) study team members
    * Prepare Clinical Study Protocol, ICF, and review study report and publication
    * Develop and manage study Project timelines and Budget, resources; mitigate potential risk/safety and quality, select
    CROs and vendors in both national and international trials.
    * Manage clinical development, and optimization through Proof-of-Concept and First-in-Man..studies.
    * Perform review of Data's and provided consolidation information for Dose Escalation Meeting's with study
    participation investigators
    * Accounted for program specific standard, (e.g. eCRF or pCRF, outsourced specifications, data monitoring and validation
    plan) developed and applied across all trials to ensure consistencies in clinical dossiers
    * Selected, managed and supported networking relationship with KOLs in publishing and presenting scientific findings and
    ad-hoc advisory board for products; oversaw strategic alliance with CROs and vendors in collaboration with clinical
    documents and oversight of outsourced activities to ensure delivery against the contracted scope of work
    * Managed the development of the clinical program documents and other regulatory affairs communication documents;
    (IB, ASR, SAP, IMPD), RMP, PSUR, as well as and responses to health authorities findings
    * Developed AEs, SAE´s & its reconciliations, (narrative documents)
    * Leaded the clinical trial data and ongoing medical/scientific review, data`s analysis and interpretation for the development
    of clinical trial reports, publications and internal/external presentations.
    * Delivered medical expertise and medical evaluation of questions regarding patients care
    * Supported multidisciplinary task forces for continuous improvement and other management objectives

  • 04/2008 - 11/2009

    • PARI Pharma GmbH
  • Manager, Clinical Development and Drug Safety (QPPV)
  • PARI Pharma GmbH (Medical Devices and Drug Development) - Munich,

    * Manage all activities associated with clinical studies in accordance with the designated product development
    project. Oversee clinical trial progress and ensure compliance with internal SOPs, GCP guidelines, and other
    regulatory requirements for Phase II & III projects
    * Perform medical monitoring, review clinical data and supported KOLs, (reviewed questions related to trial procedures and
    patients eligibilities)
    * Lead the management of IIT studies; Line management
    * Monitor, Co-monitoring, organized Investigator's meetings and trainings,
    * Perform literature reviews, inquiries and writing position papers when required
    * Organising logistics of various oversight and advisory board; selected and managed CRO; organized project kick-off
    meeting with CROs and sites; and attend project team meetings throughout the study
    * Provide inputs, design and develop clinical trial protocols, amendments, CRF, master ICF, developed monitoring plans, and
    related documents, review ongoing scientific clinical data, analyzing trial, reporting and publishing
    * Manage interactions with Global Clinical Development Operations and other relevant functions including Drug Supply
    Management and company local medical organizations.
    * Created budget plans; performed audit at sites, maintains study timelines, compliance contracts.




    * Provide support in the medical writing, publications and posters presentation in national and international congresses
    * Oversaw the preparation of IND, IMPD documents; drafted EMEA and FDA submissions docs.

  • 05/2005 - 03/2008

    • PRA GmbH
  • Senior Clinical Project Manager (Phases III/IV)
  • PRA GmbH - Mannheim, Germany

    * Manage projects and investigative sites, conducted pre-study, initiation, monitoring, co-monitoring and closure visits, in
    accordance with ICH-GCP, and SOPs Procedures
    * Perform feasibility (country and site selection), to identy potential investigators
    * Organize customer bid defense and investigator meetings; prepared project status reports
    * Prepare timely and accurate ethics committee submission documents
    * Liais with investigational site staff, sponsors, projects teams, central laboratories, Investigational Medicinal Product
    distributors, and data management including TMF
    * Perform medical review and prepare study specific templates and documents, handbooks, Protocol, PIS, ICF,
    and completion guidelines
    * Coordinated study team meetings and customer teleconferences, minutes meeting etc
    * Developed Standard Operating Procedures (SOPs), reviewed processes, DB systems (CTMS)
    * SAE narratives management according to regulatory reporting procedures
    * Collect, filed and archived essential and other study related documents
    * Manage IIT trials, reviewed report for approval
    * Train and Mentor study team members, CRAs
    * Create budgets and forecasts, and managed clients expectations by open line communication
    * Support documents review and ethics Submissions

  • 04/2004 - 04/2005

    • IFE GmbH
  • Clinical Scientist/Medical Monitoring (Phase I, II, III)
  • IFE GmbH, Essen, Germany

    * Review protocol, monitors sites, updated TMF, developed protocol, managed data, SAE collection and reporting,
    contributing in clinical trials report writings, CRF, DB systems

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