Oruka TherapeuticsNASDAQ: ORKA: Develops long-acting biologics for chronic skin and inflammatory diseases.
2+ YOEBachelor's degree preferred; 2–5 years in clinical research, data management, or trial operations; eCOA/IRT, EDC, CRO, GCP, ICH, and clinical trial experience.
eCOA, ePRO, IRT, Suvoda, EDC, Medidata Rave, Veeva CDMS, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Teams, Trial Master File (TMF), eTMF, GCP, ICH
Stoke TherapeuticsNASDAQ: STOK: Develops RNA-based therapies for severe genetic disorders.
8+ YOEBachelors in life sciences required, 8+ years clinical supply management experience, IRT and inventory/forecasting expertise, GMP/GDP knowledge, Microsoft Excel/PowerPoint/Project proficiency.
Kailera Therapeutics: Developing clinical-stage injectable and oral therapies for obesity.
6+ YOE6+ years clinical research experience, advanced proficiency with EDC/IRT/eCOA, ability to synthesize operational metrics into risk-mitigation workflows, strong interpersonal and relationship-management skills.
ModernaNasdaq: MRNA: Develops and manufactures messenger RNA medicines and vaccines.
3+ YOERequires 3–6 years of clinical supply systems experience, a science-based bachelor's degree, IRT expertise, vendor relationship experience, regulatory knowledge, and proficiency with Microsoft Office tools.
IRT, Electronic Data Capture (EDC), electronic Trial Master File (eTMF), Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft SharePoint
MBX BiosciencesNASDAQ: MBX: Develops precision peptide therapies for endocrine and metabolic disorders
12+ YOE12+ years clinical supply chain experience with labeling, packaging, distribution, inventory control, forecasting, IRT setup/maintenance, vendor management, GMP and global regulatory knowledge; bachelor's or master's in a scientific discipline.
5+ YOEBS/MS in relevant discipline with 5+ years clinical data management experience (sponsor/CRO), hands-on EDC/IRT experience, CRF design, data reconciliation, GCP knowledge, and strong communication and critical thinking.
AlkermesNASDAQ: ALKS: Develops medicines for psychiatric and neurological disorders.
10+ YOEMaster's with 10+ years or Bachelor's with 12+ years in clinical supply chain; APICS certifications preferred; experience with demand planning, IXRS/IRT, N-Side, and global clinical supply; strong communication and project leadership.
N-Side, IXRS, IRT, Microsoft Excel, Microsoft PowerPoint, Smartsheet, SharePoint, Microsoft Project, Planview
Regeneron PharmaceuticalsNASDAQ: REGN: Discovers and develops medicines for serious diseases.
8+ YOEBachelor's and 8+ years relevant pharma/biotech experience with 5+ years in clinical supply management; knowledge of IRT/IVRS/IWRS; vendor, budget, and inventory management; regulatory compliance.
Associate Director, Global Clinical Supply Chain Operations Lead
Lexington, Massachusetts, United States
$154k-$243k/yrHybridFull Time
TakedaTokyo Stock Exchange / New York Stock Exchange: 4502 / TAK: Researches, develops, and manufactures prescription pharmaceutical medicines.
8+ YOEDegree in pharmacy or scientific field preferred, 8+ years pharma/contract experience preferred, strong cGMP knowledge, IRT and SmartSupplies experience, vendor and budget management, Excel and project management skills.
Interactive Response Technology (IRT), Smart Supplies Database (PMD), Microsoft Excel, Microsoft Project
Ascend Learning: Provides educational software and certifications for healthcare professionals.
3+ YOEPhD in measurement/educational psychology, 3+ years relevant experience, proficiency in SAS, R, Python, experience with CTT/IRT, test development, standard-setting, research design, database basics, and strong communication skills.
SAS, R, Python, Classical Test Theory (CTT), Item Response Theory (IRT)
ArisGlobal: Cloud-based software for life sciences drug development and safety.
5+ YOEBachelor's in CS/IS/CE required; 5+ years software development experience; experience with LSMV, ARISg, IRT/OST, ESM, LSRA and Cognos; responsibilities include design, configuration, deployment, integration, and performance tuning; US travel required.
Total Safety Suite, LSMV, ARISg, IRT/OST, ESM, LSRA, Cognos
4G Clinical: Cloud-based randomization and trial supply management software for clinical trials.
1+ YOE1–3 years clinical research experience; RTSM/IRT delivery, software implementation and testing; project management with cross-functional teams; knowledge of GCP/21 CFR Part 11 a plus; bachelor\u0002s degree or equivalent.
Korro BioNASDAQ: KRRO: Develops RNA editing medicines for rare and prevalent diseases.
10+ YOEBachelor's or advanced degree and 10+ years in pharmaceutical/biotech supply chain; experience with global clinical trial supply, vendor management, IRT/IXRS, cold chain logistics, GMP/GDP and regulatory compliance; strong communication and project management skills.
Kiniksa PharmaceuticalsNASDAQ: KNSA: Developing and commercializing therapies for cardiovascular and inflammatory diseases.
7+ YOEBachelor’s degree in health or biological science; 7+ years clinical operations with global trials; 3+ years as a clinical study lead or project manager; cardiovascular/rare disease experience preferred.
Electronic Data Capture (EDC), IRT, Clinical trial management software, Microsoft Office
Tango TherapeuticsNasdaq Capital Market: TNGX: Develops precision cancer medicines using synthetic lethality principles.
5+ YOE5+ years trial management; 3+ years site management; Bachelor's degree in Life Sciences, Pharmacy, or related field; global clinical development experience; oncology preference; strong knowledge of ICH-GCP, FDA/EU guidelines; experience with trial systems and vendor oversight; travel flexibility.
N-SIDE: Optimizes life sciences and energy operations through AI software.
10+ YOE10+ years in clinical trials/clinical supply chain/RTSM; strong CTS network; experience in client relationship management, business development or technical sales; ability to influence senior stakeholders; must be based in the United States.
BeOne MedicinesNasdaq: ONC: Develops and sells innovative medicines for treating cancer worldwide.
5+ YOEMaster’s in computer science, engineering, or related field with 5 years’ experience, or bachelor’s with 7 years’ experience. Requires clinical systems, data warehouse, SOP, ticketing, and clinical trial experience.
Medidata Rave, Oracle Inform, Oracle CTMS, Medidata CTMS, Jira, ServiceNow, CTMS, IRT, MDM, CDISC, 21 CFR Part 11, ICH GCP