Principal Clinical Scientist, Clinical Development - Hematology

Overview

In this role you will contribute to Hematology clinical development programs, ensuring scientifically sound design, safety, and data integrity. You will translate strategy into actionable study deliverables, author and review key documents, and collaborate across functions to drive timely regulatory submissions. You may lead a Clinical Development Program and oversee medical monitoring to safeguard patient safety. The position supports impactful publications and external oversight committees, within a culture focused on patient needs and collaboration.

Pay / Benefits

• hybrid work arrangement
• competitive base salary
• incentive compensation
• equity

Responsibilities

• Contribute to scientific development of clinical programs in Hematology
• Provide input to ensure safe, efficient, compliant execution of programs
• Author/contribute to program and study documents and training materials
• Develop medical monitoring oversight strategy for studies and ensure patient safety and data integrity
• Potentially lead a Clinical Development Program
• Contribute to authorship/review of manuscripts and conference abstracts
• Collaborate with cross-functional stakeholders to translate strategy into deliverables
• Contribute to scientific analysis and interpretation of data and writing of study reports and regulatory submissions
• Manage processes to support external study oversight committees (steering, IDMC, adjudication)

Key requirements

• 4+ years in one or more R&D functions in biotech/pharma (PhD)
• 6+ years (MS) or 8+ years (BS) experience in R&D functions
• 3+ years of clinical development research experience
• Proven knowledge of drug development and manufacturing processes (CMC, non-clinical, clinical, Regulatory Affairs)
• Strong cross-functional collaboration能力
• Excellent oral and written communication
• Attention to detail in processes and documentation
• Ability to work independently and in a team
• Experience overseeing CROs

• cross-functional collaboration
• attention to detail
• independence and team orientation
• drug development processes (CMC, non-clinical, clinical, Regulatory Affairs)
• oversight of CROs
• clinical study design and execution

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