Global Clinical Scientist Lead, Hematology Programs

CSL Plasma; Waltham (MA); Hybrid; USD 188,000 - 222,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

CSL Plasma in Waltham, MA seeks an Associate Director, Global Clinical Scientist to lead clinical development in hematology. The role includes scientific strategy, study oversight, and collaboration across functions to ensure high-quality outputs and compliance with regulatory standards.

The position requires extensive clinical research experience, advanced degrees, and demonstrated leadership in matrix teams.

Qualifications

• Bachelor's degree in a science-related field is required.
• Advanced degree (MSc, PhD) in Science, PMP certification, or equivalent is preferred.
• 8+ years of clinical research experience in one or more Clinical Development functions within biotech or pharmaceutical industry.
• Experience in regulatory submissions (IND, NDA/BLA, MAA, PIP) and interactions with health authorities.
• Experience leading a matrix team or complex clinical programs is a plus.
• Experience evaluating external opportunities, doing scientific due diligence, or contributing to business development activities is preferred.

Responsibilities

• Provide scientific leadership in developing clinical programs within the Hematology therapeutic area.
• Provide input for safe, efficient, and timely execution of studies with high quality outputs.
• Author or contribute to study documents and training materials aligned with the scientific strategy.
• Collaborate with cross-functional stakeholders to translate study protocols into operational deliverables.
• Define and implement medical monitoring and oversight strategies to ensure patient safety and data integrity.
• Manage processes and liaisons for external study oversight committees (e.g., steering, DMC, adjudication).
• Contribute to analysis, interpretation, reports, publications, and regulatory submission documents.
• Support program-level regulatory interactions and development of the Clinical Development Plan.

Skills

Clinical research leadership

Cross-functional collaboration

Strategic thinking

Communication

Education

Bachelor's degree in Science

MSc/PhD in Science

PMP certification or equivalent

Job description

CSL Plasma in Waltham, MA seeks an Associate Director, Global Clinical Scientist to lead clinical development in hematology. The role includes scientific strategy, study oversight, and collaboration across functions to ensure high-quality outputs and compliance with regulatory standards.

The position requires extensive clinical research experience, advanced degrees, and demonstrated leadership in matrix teams.