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CSL
CSL
H1B Visa SponsorBiotechnologyHealthcarePharmaceuticals
CSL is a global biotechnology and healthcare company developing biotherapeutics and vaccines for people living with serious and rare diseases. Its operations include CSL Behring, which provides treatments for immunodeficiency, hereditary bleeding disorders, and Alpha-1 Antitrypsin Deficiency; CSL Seqirus, a major influenza vaccine provider; and CSL Vifor, focused on iron deficiency and nephrology. Supported by a broad research and development network, CSL works across plasma fractionation, recombinant protein technology, cell and gene therapy, and vaccines. Headquartered in Melbourne, Australia, the company serves patients in more than 100 countries and offers career opportunities across research, manufacturing, healthcare, and biotechnology.
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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.

USUnited StatesMAMassachusettsPAPennsylvaniaOn-siteFull-timeLeadEnglish RequiredClinical Research
PMP

Description

  • 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

Requirements

  • 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

Benefits

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

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