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68 fresh jobs found

Director, Clinical Pharmacology Lead
USA - Pennsylvania - Plymouth Meeting, Amerika Birleşik Devletleri

Biomarker Strategy Modeling and Simulation Pharmacometrics Pharmacodynamics Translational Medicine Pharmacokinetics Clinical Pharmacology Study Design ICH +14

Senior Full Time

USD 150K+

Regulatory Manager
Remote, United States

Precision for Medicine

Clinical Study Interpretation Scientific Advice Drug development process ICH GCP Regulatory strategy Regulatory Guidance Pharmaceutical Development ICH Precision Medicine +21

USD 106K+

Regulatory Manager
Remote, United States

Precision Medicine Group

Clinical Study Interpretation Scientific Advice Timeline development ICH GCP Regulatory strategy Regulatory Guidance Pharmaceutical Development ICH Precision Medicine +25

USD 106K+

Start Up Lead
Remote, United States

Precision for Medicine

Site start-up Critical path planning Budget negotiation ICH Guidelines Documentation Management ICH Precision Medicine Regulatory Submissions Clinical operations +19

Senior Mid Full Time

USD 106K+

Start Up Lead
Remote, United States

Precision Medicine Group

Site start-up Critical path planning Budget negotiation Contracts Management Good Clinical Practice ICH Guidelines Documentation Management ICH Precision Medicine +23

Senior Full Time

USD 106K+

Manager, Global Clinical Monitoring
Remote, United States

Precision for Medicine

Project resourcing Data capture Electronic Data Capture Site visits Clinical Monitoring Regulatory Guidance Performance Evaluation Precision Medicine ICH +26

Senior Mid Full Time

USD 113K+

Manager, Global Clinical Monitoring
Remote, United States

Precision Medicine Group

Project resourcing Tracking systems Electronic Data Capture Site visits Data Review Regulatory Guidance Performance Evaluation ICH Precision Medicine +30

Senior Mid Full Time

USD 113K+

Director, External Data
Cambridge, MA, United States

Sarepta Therapeutics

Data transfer Gene editing RNA Gene therapy Clinical Data Management ICH Process Automation KPI development Clinical operations +10

Exec Senior Full Time

USD 180K+

Senior Manager, Regulatory Affairs Device
Cambridge, MA, United States

Sarepta Therapeutics

Global Regulatory Strategy Gene editing RNA Gene therapy Regulatory strategy ICH Guidelines Documentation Management ICH Regulatory Submissions +8

Senior Full Time

USD 132K+

Associate Director, Safety Scientist
Cambridge, MA, United States

Sarepta Therapeutics

Safety reporting Gene editing RNA Signal detection Gene therapy Medical Review Pharmacovigilance ICH Regulatory Submissions +9

USD 156K+

QA Manager, DP Commercial Small Molecule
Remote (US), United States

Small Molecule Quality Risk Management Cross-Department Collaboration CMC CGMP Good Manufacturing Practices Quality Systems Audit Management Incentive Compensation +38

USD 104K+

Principal Biostatistician
USA-Maryland-Remote, United States

Edwards Lifesciences

Clinical database development Medical device research Clinical Affairs Data Quality Assurance Regulatory Guidelines Statistical methods ICH Biostatistics Statistical modeling +32

Senior Mid Full Time

USD 129K+

Senior Manager, Clinical Management (Early Phase)
Remote, United States

Otsuka Pharmaceutical Companies

Clinical study documents Trial Management Clinical Management Clinical protocols Good clinical practices CTMS ICH Guidelines Impactful Communication Pharmaceutical Development +31

Senior Full Time

USD 146K+

Senior Manager, Clinical Management (CNS)
Remote, United States

Otsuka Pharmaceutical Companies

Clinical study documents Trial Management Clinical Management Good clinical practices CNS CTMS ICH Guidelines Impactful Communication Pharmaceutical Development +31

Senior Full Time

USD 146K+

Clinical Strategy and Solutions Specialist - Study Modeling (Contract)
California, United States - Remote

Faro Health Inc.

Protocol comprehension Study modeling EConsent EPRO TMF IRT ECOA EDC Information Governance +21

USD 100K+

Clinical Study Specialist
Armonk, United States

Trial Management Systems Trial Management Case Report Forms Clinical trial execution ICH Standard Operating Procedures SOPS Drug Development Clinical trials +18

USD 92K+

Associate Director, Global Pharmacovigilance Quality Management
Cambridge, MA, United States

Sarepta Therapeutics

Gene editing RNA MS Visio Gene therapy Systems Thinking Pharmacovigilance ICH Regulatory Affairs Quality Management +9

USD 156K+

Operational Strategy Director - Clinical Trials
Remote, United States

Precision Medicine Group

Data sciences Laboratory expertise Operational strategy Clinical Trial Management Regulatory Guidance Budget development ICH Study Design Pharma +42

Exec Senior Full Time

USD 144K+

Operational Strategy Director - Clinical Trials
Remote, United States

Precision for Medicine

Data sciences Laboratory expertise Operational strategy Clinical Trial Management Regulatory Guidance ICH Study Design Pharma Precision Medicine +39

Exec Senior Full Time

USD 144K+

Associate Director, Medical Writing
Cambridge, MA, United States

Sarepta Therapeutics

Gene editing RNA Scientific Writing Gene therapy SOP Development Medical Writing ICH Regulatory Submissions Clinical Documentation +7

USD 156K+

Associate Director, Analytical Chemistry
Remote Worker

Stability studies Control strategies Analytical reference standards Method optimization Technical investigations Method development Analytical Chemistry Characterization ICH +9

Senior Mid Full Time

USD 165K+

Senior Manager, Digital Clinical Operations - Solutions Analytics
Remote (US), United States

RBQM Site payments Data Quality Standards Clinical Systems Clinical Solutions UAT CTMS Clinical Trial Management Incentive Compensation +64

Senior Full Time

USD 133K+

Director, QMS Process Owner – Deviations, Product Quality Complaints, CAPA
Remote (US), United States

ICH Q10 Deviation Management Corrective and Preventive Actions ISO 9001 QMS CAPA Industry Standards Incentive Compensation Change Control +38

Exec Senior Full Time

USD 164K+

Senior Manager, Digital Clinical Operations - Data Analytics
Remote (US), United States

Data masking Data Pipeline Management Data Profiling Data Pipeline Incentive Compensation Data Lake Visualization Tools Lifecycle Management ICH +60

Senior Full Time

USD 133K+

Associate Vice President – Global Development, Immunology
US: USA Remote, United States

Eli Lilly and Company

Medical expertise Data Dissemination Medical research Clinical trial data Clinical Strategy Good clinical practices Clinical Pharmacology Patient Safety Protocol Development +49

Senior Mid Full Time

USD 252K+

Clinical Study Associate Manager
Armonk, United States

Trial Management CFR Recruitment Strategies Inspection Readiness Good Clinical Practice Clinical Trial Management Regulatory Guidelines Microsoft Applications ICH +20

USD 108K+

Director, Digital Clinical Operations Data Products Head
Remote (US), United States

Digital Operations Data Pipeline Management Data Standards Data Pipeline Visualization Tools Lifecycle Management ICH Statistical methods Data storage +60

Exec Senior Full Time

USD 168K+

Senior Director, Quality Sciences and Knowledge Management
Remote (US), United States

Corrective and Preventive Actions Advanced Quality Technologies Quality Systems CAPA Patient Safety ICH Knowledge Management Employee stock purchase plan Financial excellence +32

Senior Full Time

USD 197K+

Director of Digital Product Management
US - California - Thousand Oaks - Field/Remote, United States

Market Strategies EMA Real-world data Digital Product Management Product Lifecycle Biopharma GxP Regulatory Guidelines Regulatory knowledge +55

Exec Senior Full Time

USD 194K+

Director QMS Process Owner Training and Document Management
Remote (US), United States

ICH Q10 Corrective and Preventive Actions Deviation Management ISO 9001 QMS CAPA Industry Standards GxP Change Control +43

Exec Senior Full Time

USD 164K+

Senior Director, Digital Quality Management Systems (QMS) Strategy and Operations
Remote (US), United States

Digital quality management systems GxP Regulations Quality Systems QMS Quality Management Systems GxP ICH Employee stock purchase plan Financial excellence +30

Senior Full Time

USD 197K+

Senior Director, QMS Process Oversight and Performance Management
Remote (US), United States

Advanced Quality Technologies Corrective and Preventive Actions Quality Systems QMS CAPA Patient Safety ICH Knowledge Management Employee stock purchase plan +34

Senior Full Time

USD 197K+

Clinical Scientist - ID/Vaccines
USA - Pennsylvania - North Wales (Upper Gwynedd), United States

Medical field Clinical drug development Medical Monitoring Scientific Acumen ICH Clinical Studies Vaccines Drug Development Technical Writing +40

USD 94K+

Specialist, Clinical Operations - Global Site Budgets and Payments
USA - New Jersey - Rahway, United States

Continuous process improvement Clinical trial operations Animal Health Products Budget development Regulatory Guidelines Animal Health ICH Vaccines Operational +52

USD 94K+

Senior Clinical Research Associate (Remote Position)
Field Non-Sales (USA), United States

CAR-T Site Management Clinical Trial Management ICH Drug Development FDA Clinical trials Data Collection Clinical Research +16

USD 103K+

FSP Principal Biostatistician- Early Phase Clinical Development(PK)
Durham, North Carolina, United States of America

Non-compartmental PK analysis Exploratory analyses Sample size calculations Biomarker analyses CDASH Clinical trial protocols Statistical analysis plans Simulations SDTM +31

Senior Full Time

USD 131K+

Director, Small Molecule AR&D Strategic Operations Lead
USA - New Jersey - Rahway, United States

Operational control strategy Scientific Rigor Pharmaceutical operations FDA guidelines Strategic operations Process research Scientific Excellence Analytical Research Operational Leadership +48

Senior Full Time

USD 153K+

Senior Clinical Scientist - Cardiovascular & Respiratory
USA - New Jersey - Rahway, United States

Medical field Clinical drug development Medical Monitoring Deviations Scientific Acumen PharmD Respiratory Matrix Environment ICH +51

Senior Mid Full Time

USD 114K+

Assoc Prin. Scientist, Engineering
USA - Pennsylvania - West Point, United States

Pharmaceutical process development Process robustness Risk-based approaches ICH principles Oral solid dosage forms Process performance qualification Interfaces Formulation Development Drug product development +61

USD 139K+

Clinical Research Associate Manager - Southeast Region
USA - New Jersey - Rahway, United States

Trial Management Systems Performance Appraisal Clinical trial execution Documentation Practices Site Management Good Documentation Practices Good Clinical Practice ICH GCP Performance reviews +52

USD 139K+

Associate Director, Pharmacovigilance Operations
New York, New York

Axsome Therapeutics Inc

Case Processing Safety reporting CNS Disorders Compliance monitoring Medical Writing Medical Information Pharmacovigilance ICH Regulatory Submissions +12

Senior Mid Full Time

USD 170K+

Senior Clinical Scientist - Atherosclerosis and Metabolism
USA - New Jersey - Rahway, United States

Medical field Clinical drug development Metabolism Deviations Medical Monitoring Scientific Acumen PharmD Matrix Environment ICH +50

Senior Mid Full Time

USD 114K+

Associate Director, CRA Functional Manager
Remote (US), United States

CRA management GCP guidelines Site identification Data management systems Project oversight Site Management CTMS Metrics Development Regulatory Guidelines +42

Senior Mid Full Time

USD 140K+

Assoc. Dir., Engineering
USA - Pennsylvania - West Point, United States

Sustainable materials Quality system regulations Manufacturability considerations Biopharmaceutical packaging Design and modeling tools Materials Design Collaborative partnerships Sterile Products Packaging science +71

Senior Full Time

USD 126K+

Associate Principal Scientist, Chemical Engineering R&D
USA - New Jersey - Rahway, United States

Flocculation Experimental Program Development Product Separation Technologies Enzymatic Catalysts Downstream Bioprocess Development Centrifugation Bioreactor systems Bioprocess Development Statistical design of experiments +83

Senior Mid Full Time

USD 139K+

Associate Clinical Research Medical Director , Immunology
Remote Position (USA), United States

Mitigation Planning Ethics Committee Interaction Innovation in Clinical Trials Medical Leadership Recruitment Strategy Clinical trial operations Data Quality Assurance Protocol Development Scientific Expertise +45

Senior Mid Full Time

USD 204K+

Study Start-Up Clinical Research Associate/Specialist (Remote)
Remote Position (USA), United States

Site selection Site Management Clinical Trial Management ICH Drug Development Clinical operations Conflict Resolution Clinical trials Clinical Research +19

Senior Mid Full Time

USD 114K+

Study Start-Up Manager (Remote)
Remote Position (USA), United States

Site selection Patient Enrollment Matrix management Matrixed environment ICH Drug Development FDA Regulatory Affairs Clinical operations +21

Senior Mid Full Time

USD 114K+

Senior Feasibility Associate
Remote, United States

Precision for Medicine

Feasibility Analysis Web-based Platforms Site identification Clinical protocols Operational strategy ICH Precision Medicine Pharma MS PowerPoint +21

Senior Full Time

USD 88K+

Senior Biostatistician (FSP)
Durham, North Carolina, United States of America

Biomarker analyses Multivariate analyses Exploratory analyses CDASH Bayesian Methods Clinical trial protocols Statistical analysis plans Simulations ADaM +30

Senior Full Time

USD 122K+

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