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CSL
CSL
Sponsor pentru viza H1BAsistență medicalăBiotehnologieProduse farmaceutice
CSL este o companie globală de biotehnologie și servicii medicale care dezvoltă produse bioterapeutice și vaccinuri pentru persoanele care trăiesc cu boli grave și rare. Operațiunile sale includ CSL Behring, care oferă tratamente pentru imunodeficiență, tulburări ereditare de coagulare și deficit de alfa-1 antitripsină; CSL Seqirus, un furnizor important de vaccinuri antigripale; și CSL Vifor, axată pe deficitul de fier și nefrologie. Susținută de o rețea extinsă de cercetare și dezvoltare, CSL activează în domeniul fracționării plasmei, al tehnologiei proteinelor recombinante, al terapiilor celulare și genice și al vaccinurilor. Cu sediul în Melbourne, Australia, compania deservește pacienți din peste 100 de țări și oferă oportunități de carieră în cercetare, producție, servicii medicale și biotehnologie.
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Locurile de muncă ale companiei

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.

USStatele Unite ale AmericiiMAMassachusettsPAPennsylvaniaLa sediuNormă întreagăLiderLimbă Obligatorie: englezăCercetare clinică
PMP

Descriere

  • 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

Cerințe

  • 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

Beneficii

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

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