Clinical Development Lead

Clinical Development Lead Overview

• The Clinical Development Lead will oversee early clinical development of oncology assets, focusing on innovative therapeutic approaches and translational medicine strategies.
• Collaborate with global asset teams to design and execute clinical trials from preclinical development through phase 2a.
• Lead efforts to validate experimental models and contribute to human target validation studies for oncology treatments.
• Coordinate cross-functional teams including regulatory, safety, biostatistics, biomarkers, and clinical operations for successful trial execution.
• Provide medical expertise to guide preclinical data generation and interpretation for oncology assets.
• Develop strategies for rapid proof-of-concept studies, ensuring robust data for early Go/No Go decisions.
• Engage with external experts, investigators, and clinical trial vendors to ensure high-quality trial outcomes.
• Contribute to the advancement of oncology treatments addressing unmet medical needs in a collaborative environment.

Clinical Development Lead Key Responsibilities & Duties

• Design and oversee early clinical trials, including First-In-Human studies, for oncology assets.
• Coordinate cross-functional teams to ensure seamless execution of clinical studies.
• Provide medical monitoring and safety oversight during clinical trials.
• Review and interpret clinical trial results, authoring relevant documentation and reports.
• Collaborate with research scientists and regulatory experts to integrate translational medicine strategies.
• Ensure compliance with Good Clinical Practice (GCP) standards and regulatory requirements.
• Engage with external stakeholders, including investigators and ethics committees, to support trial objectives.
• Drive decision-making processes for dose escalation and study design adjustments.

Clinical Development Lead Job Requirements

• Doctor of Philosophy (PhD) in a relevant field; MD/PhD preferred.
• Minimum 3 years of clinical research experience, including early-phase trials and biomarker data interpretation.
• Proven expertise in designing and executing early development clinical trials (Phase 1/2a).
• Strong knowledge of GCP practices and regulatory compliance.
• Experience in global pharmaceutical settings and cross-functional team leadership.
• Demonstrated ability to apply biomedical knowledge to clinical and preclinical research.
• Excellent communication skills for global interactions and documentation.
• Proficiency in emerging digital and AI-driven tools for clinical research.