CSL
CSL
CSL — ауыр және сирек кездесетін аурулармен өмір сүретін адамдарға арналған биотерапиялық препараттар мен вакциналар әзірлейтін жаһандық биотехнологиялық және денсаулық сақтау компаниясы. Оның қызметіне иммун тапшылығы, тұқым қуалайтын қан кету бұзылыстары және Альфа-1 антитрипсин тапшылығын емдеуге арналған препараттар ұсынатын CSL Behring; тұмауға қарсы вакциналардың ірі жеткізушілерінің бірі CSL Seqirus; темір тапшылығы мен нефрологияға бағытталған CSL Vifor кіреді. Кең ауқымды зерттеу және әзірлеу желісінің қолдауымен CSL плазманы фракциялау, рекомбинантты ақуыз технологиясы, жасушалық және гендік терапия, сондай-ақ вакциналар бағыттарында жұмыс істейді. Штаб-пәтері Австралияның Мельбурн қаласында орналасқан компания 100-ден астам елдегі пациенттерге қызмет көрсетеді және зерттеу, өндіріс, денсаулық сақтау мен биотехнология салаларында мансап мүмкіндіктерін ұсынады.

Principal Clinical Scientist, Hematology Clinical Development - Onsite

Lead scientific contributions to CSL’s hematology clinical development programs. Support study execution, clinical data interpretation, regulatory documentation, medical monitoring, and external oversight committees.

Сипаттама

  • Support scientific planning for hematology clinical development programs and individual studies
  • Provide clinical development expertise to help deliver assigned programs safely, efficiently, on schedule, to high quality, and in compliance with requirements
  • Develop and review program and study documents and training materials, including clinical development plans, investigator brochures, protocols, eCRFs, ICFs, study reference manuals, and investigator training
  • Help design and execute medical monitoring strategies that protect patient safety and data integrity, including ongoing blinded-data review
  • May lead the development of a Clinical Development Program
  • Help prepare and review manuscripts, conference abstracts, and related scientific materials
  • Work with internal and external cross-functional partners to convert clinical strategy and protocols into operational deliverables
  • Analyze and interpret clinical data
  • Prepare clinical study reports, scientific meeting presentations, peer-reviewed publications, and regulatory submission materials
  • Coordinate processes and relationships supporting external study oversight committees, including steering, independent data monitoring, and adjudication committees

Талаптар

  • PhD, master’s degree, or bachelor’s degree in a science-related discipline
  • An advanced degree such as an MSc or PhD in a science-related discipline is preferred
  • PMP certification is preferred
  • PhD holders need at least 4 years of experience in one or more biotechnology or pharmaceutical R&D functions
  • MS holders need at least 6 years of experience in one or more biotechnology or pharmaceutical R&D functions
  • BS holders need at least 8 years of experience in one or more biotechnology or pharmaceutical R&D functions
  • At least 3 years of clinical research experience
  • Deep knowledge of pharmaceutical drug development and manufacturing processes spanning CMC, non-clinical, clinical, and Regulatory Affairs activities
  • Ability to collaborate across functions in a matrix organization
  • Strong written and verbal communication skills
  • High attention to detail in processes, communications, and documentation
  • Demonstrated ability to work independently and collaboratively
  • Creative problem-solving ability
  • Experience overseeing CROs

Артықшылықтар

  • CSL benefits are available; consult “How CSL Supports Your Well-being” for details

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