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.