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  • Medical Affairs Expert

    Jennifer Hayes

    20 years of experience 0 projects USA Research & Development
    Medical Affairs AdvisoryAdvisory CommitteeBudget planning & managementClinical data standardsClinical development planClinical trial diversificationDiagnosticsInfectious diseaseInvestigational/pre-marketInvestigators/Site SelectionKOL LiaisonLarge pharma experienceLate (Phase 2 or 3)Lifecycle managementliterature searchesMedical AffairsMedical education & trainingMetricsMicrosoft WordPatient engagementProgram ManagementPublicationsRare diseaseReal World Evidence (RWE)Registry development and analysesResearchSmall pharma experienceTraining developmentTraining execution/managementTraining plans
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    Jennifer M. Hayes is a highly accomplished and experienced Medical Affairs professional with over 21 years of experience in the hospital & healthcare, and life science industries. As a recognized leader in the field of infectious diseases, Jennifer has demonstrated exceptional leadership skills, effectively managing teams and achieving company goals. Her extensive expertise in medical affairs has allowed her to successfully manage and oversee a variety of projects and initiatives. With a career spanning multiple companies and roles, Jennifer has…

  • Statistical Programmer

    Deepthi Pabbisetty

    15 years of experience 1 project USA Research & Development
    Biometrics Statistical programming
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    Statistical Programming

  • ASAP Process, Inc.

    0 years of experience 0 projects USA Research & Development
    Biometrics Statistical programming
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    Ophirex Statistical Programmer- DP

  • ASAP Process, Inc.

    0 years of experience 0 projects USA Research & Development
    Statistical programming
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    Ophirex Statistical Programmer- UP

  • ASAP Process, Inc.

    0 years of experience 0 projects USA Research & Development
    Biostatistics
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    Ophirex Biostatistician

  • CMC Process, Facility Development Expert, Quality and Regulatory

    Fenton Fong

    30 years of experience 0 projects Canada Research & Development
    CMCQuality CMCManufacturingProcess developmentQualityRegulatory CMC
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    .CMC, MANUFACTURING & PROCESS DEVELOPMENT:

    Experienced with small molecule synthesis and biologics API manufacturing (recombinant proteins, MaB’s, secondary metabolites); Comprehensive experience and GMP knowledge in technologies for sterile, parenteral, liquid, and solid dosage forms manufacturing, fermentation, downstream processing, aseptic processing, sterility assurance; Experienced with conceptual design process, construction, commissioning & qualification of production facilities and qualification of pharmaceutical equipment and cleanroom facilities; Production process scale-up development, cost and yield analysis/improvement of production processes; Identification and testing of product quality attributes,…
  • Biostatistician, Data Science and Visualization Expert

    Alexander Schacht

    20 years of experience 0 projects Germany Research & Development
    Biometrics BiostatisticsData visualizationHEORMedical AffairsProduct LaunchReal World Evidence (RWE)
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    My personal vision is to ensure that payers, physicians, and patients have the right evidence

    at the right time in the right format to make the right decisions for the benefit of patients. My

    professional activities all support this long-term vision.

    As a statistician with 20+ years experience in healthcare (academia, pharmaceutical

    companies and service…

  • Strategy and Management Consultant, Data and AI

    Manjula Kasoji

    15 years of experience 0 projects USA Market Research, Research & Development
    Data StrategyLife Science ITProgram/Project Mgmt Life Sciences ITProject management AIData scienceData visualization
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    15 years experience in strategy and management consulting and leadershipExperience in data science and AI strategy, transformation and roadmap developmentExperience in providing strategic direction and leading technology delivery programsExperience leading funding proposal efforts with a portfolio estimate of up to $150 millionExperience in strategy and planning, governance, developing and maintaining relationships with team, stakeholders and clientsExperience managing teams (data science, program managers, software engineers)Experience hiring and leading teams, including remote, distributed teams and vendors

  • Iterum

    0 years of experience 0 projects Research & Development
    Regulatory Regulatory Affairs and Strategy
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    hands on regulatory strategist

  • ASAP Process, Inc.

    0 years of experience 0 projects USA Research & Development
    Administration Business Intelligence
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    Business Development

  • ASAP Process, Inc.

    0 years of experience 0 projects USA Research & Development
    Biometrics Biostatistics
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  • Safety Statistician - ASAP Process Focus

    GBall

    30 years of experience 1 project USA Research & Development
    Aggregate safety assessment planningOngoing aggregate safety evaluation BiometricsSafety & Pharmacovigilance BiostatisticsData scienceData visualizationDrug SafetySafety AnalyticsSignal Detection
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    .

    ·         Thirty-six years of strong leadership, managing people and projects; 22 years as a Biostatistician, familiar with all phases of development, submissions, and interactions with regulatory authorities (therapeutic areas: vaccines, CV, diabetes, oncology, and others)

     

    Past 5 Years:

     

    ·         Created a Safety Statistics group embedded in the Global Vaccine Safety organization

     

    ·         Co-leading the PhUSE Safety Analytics working group (with…

  • Executive Advisor, Regulatory Affairs and Strategy

    KJ Wilson

    35 years of experience 0 projects USA Research & Development
    Regulatory Regulatory Affairs and Strategy
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    A lifetime of regulatory experience at every level, KJ Wilson has deep understanding of the pharmaceutical industry, regulatory affairs and FDA.

  • Regulatory Strategist and Drug/Biologics Innovator

    Min Young, PhD, RAC

    15 years of experience 0 projects USA Research & Development
    Regulatory Regulatory Affairs and Strategy
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    A strategic thinker with extensive hands-on experience (15+ years) developing new medicines for rare diseases or areas with high unmet medical needs. Highly regarded as a dedicated, passionate and innovative Regulatory Affairs Leader throughout career. Contributed to successes of a number of development organizations.

     Led and/or contributed to global licensing of 9+ products and development of 21+ products o Solid US, EU and global RA (GRA) working experience managing full-spectrum product development, marketing applications (NDAs/BLAs/MAAs: NMEs, 505(b)(2), hybrid), approvals…

  • Regulatory Strategist and Drug/Biologics Innovator

    Meredith Brown-Tuttle

    30 years of experience 0 projects USA Research & Development
    Regulatory Regulatory Affairs and Strategy
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    Strategy, Intelligence and Product Development: • Member of core/executive drug development teams and/or Program Team Lead • Created and managed multiple global strategies for drugs, biologics, biosimulars and combination products • Conducted regulatory research and intelligence on a global basis for various therapeutic indications/areas • Performed gap analyses to identify potential challenges to successful IND, NDA, MAA, BLA and NDI/DS filings

    Scientific Advice Meetings:

    • Wrote, managed and compiled associated packages for FDA/EU/EMA/Health Canada scientific advice meetings • Conducted in-person…

  • lisa barbadora

    0 years of experience 0 projects USA Research & Development
    Clinical AffairsClinical Operations Publications
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    1200 word content write up of 2023 Decentralized Clinical Trials predictions.  Primary input- interview of thought leader, plus individual DCT trends research.  To be published in pharmaceutical trade journal.

  • Regulatory Strategist

    Mark Mariani, M.S.

    30 years of experience 0 projects USA Research & Development
    Regulatory Regulatory Affairs and Strategy
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    Over 30 years of experience in pharmaceutical Regulatory Affairs responsible for INDs, NDAs, and FDA liaison in the therapeutic areas of Rare Disease (Transplantation, Neuroinflammation, Hematology, Renal), Dermatology, Ophthalmology, Oncology, Allergy/Asthma, and Women’s Health. Highly experienced in developing regulatory strategies in support of global development programs for small molecules and biologic products, analysis of regulatory precedent and health authority policy, and preparation for meetings with the US FDA. Skilled in the evaluation of issues across clinical and nonclinical functions and…
  • Pulmonologist, Investigator, and Clinical Development SME

    Bernt van den Blink, MD PhD

    20 years of experience 0 projects The Netherlands Research & Development
    ClinicalClinical development planKOL LiaisonMedical AffairsPharmacovigilance
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    Clinical research professional with 20+yrs academic and biotech/pharmaceutical industry experience. M.D. Ph.D. pulmonologist with expertise in (rare) respiratory, auto-immune, inflammatory and fibrotic diseases. Physician-scientist bridging basic and clinical science, thrilled to guide new discoveries through clinical development.

  • Project Leader

    Gergely Balint

    25 years of experience 0 projects USA Market Research, Research & Development
    Project/program leadership Clinical OperationsCMCDeviceMarket StrategyProject managementRegulatoryResearch and Development Advisory CommitteeAlliance ManagementAutoimmune diseaseBfArMBiologicBudget planning & managementChange controlClinicalClinical development planClinical OperationsClinical Program ManagementCNSDue DilligenceFDALifecycle managementMarket landscape / opportunityPulmonary diseasesRare diseasesRegulatory Affairs and StrategyRheumatologyRisk Managementsubmission planning and trackingsubmission readiness
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    Highly accomplished leader of pharmaceutical industry with wide range of experience in project and organizational leadership. 20+ years of international drug development expertise coupled with strategic, operational and management experience.

    ◄ Core competencies include ► ★ In-depth Biopharmaceutical Industry Experience ★ Extensive Drug Development/Life Cycle Management ★ Product Development Plan Creation & Prioritization ★ Hands on Project & Program Leadership ★ US, EU, & International Experience ★ Strategic Alliance Experience

    ◄ Key Accomplishments ► ★ Developed asset for Phase…

  • Clinical Operations Consultant

    Ndukwe

    11 years of experience 0 projects USA Research & Development
    Clinical AffairsClinical OperationsDevicePharmbio Start UpQualityRegulatory 21 CFR Part 11AE/SAE ReportingAnnual ReportBioclinicaCentralized MonitoringCLIAClinical contractsClinical documentationClinical OperationsClinical Project ManagementClinical QualityClinical Trial DocumentationClinical Trials.govCNSCOACRF annotationCRF completion guidelinesCRO OversightData cleaningData CollectionData EntryDatabase lockDocument QCDocumentation and other deliverablesEarly- Phase 1 or 2eCOAeConsentEDCEHR/EMRElectronic document managementeProeSignaturesEssential documentsFDAFeasibilityGCPGCP trainingICH E6 (r2)Inform/Oracle ClinicalInformed ConsentInterim MonitoringInvestigator Site FileIRB & ethics committeeIxRSLate (Phase 2 or 3)Site managementSite Qualification and TrainingSmall pharma experienceTrial Master File remediationVeeva Vault
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    I love everything about Clinical Research. Most of all, I am passionate about getting Clinical Research Sites that are struggling or research naive back on track and audit ready. I went from doing lab work at the bench to researching the effects of the drugs made at the bench in people. If you are looking for a passionate, enthusiastic and high-performing Clinical Operations Consultant and Clinical Research Associate, look no further. I specialize in Site Management and Monitoring, Study Start-up,…

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