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10 minutes ago
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Full time
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gcp ich regulatory submissions oncology clinical development

πŸ“‹ Description

  • Lead and contribute to clinical development strategy and execution for hematology and oncology
  • Develop, author, review, and update key clinical documents (protocols, amendments, informed
  • Partner with clinical operations and cross-functional teams to support trial start-up through
  • Provide medical and scientific guidance throughout studies, addressing questions from
  • Review, analyze, interpret, and present clinical trial data, translating findings into actionable
  • Support investigator and vendor selection and build relationships with key opinion leaders and

🎯 Requirements

  • Advanced medical degree, preferably MD or equivalent, subspecialty in hematology/oncology
  • 6+ years in biotechnology, pharmaceutical, or academic clinical development environments.
  • Experience across multiple stages of clinical development; ideally led at least one study from
  • Strong understanding of global study design and the drug development lifecycle.
  • Solid knowledge of GCP and ICH guidelines; experience supporting policies and SOPs.
  • Strong scientific, analytical, organizational, written, and verbal communication skills.

🎁 Benefits

  • Base salary range of $299,800–$369,800 per year, depending on qualifications, experience
  • Eligibility for an annual bonus plan for non-commercial roles.
  • Discretionary equity awards and participation in an employee stock purchase plan.
  • Medical, dental, and vision insurance.
  • 401(k) retirement plan.
  • Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
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