Global Development Associate Director Scientist

Experteer Overview

You engage cross-functionally to ensure timely, compliant development and support regulatory submissions. You lead protocol development, study reports, and governance, shaping late-stage development with external partners and regulators. This is a mission-driven role at a company aiming to transform cancer care through science and collaboration.

• Translate clinical strategy into study concepts, protocols and related documents
• Contribute to design and implementation of clinical trials, incl. immunotherapy and cell therapy studies
• Build key internal and external relationships with clinical teams, regulators and service providers
• Ensure clinical science underpinning of studies is robust and protocols meet governance and quality standards
• Lead protocol development and delivery of clinical study reports to GCP/ICH standards
• Drive cross-functional projects to advance drugs through development stages
• Review medical and trial data to draw conclusions with Medical Director
• Support regulatory submissions with clinical components and inputs to regulatory documents (e.g., CSRs, IB, DSUR)
• Participate in or lead review of new opportunities and ESRs
• Respond timely to investigational sites regarding ICF changes and EC/IRB questions
• Collaborate on investigator training and practical execution of trials

• BS with relevant experience (minimum 3 years)
• Experience in drug development, preferably in malignant haematology clinical trials
• Strong haemato-oncology knowledge to interface with internal/external partners
• Foundational knowledge of FDA and major regulatory frameworks; solid GCP/ICH understanding
• Ability to drive protocol design, writing and implementation
• Experience with regulatory documentation and clinical study report preparation

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