Clinical Development Lead

Job DetailExperience Level DirectorDegree Type Doctor of Philosophy (PhD)Employment Full TimeWorking Type HybridJob Reference 0000021495Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful oncology research projects, advancing innovative therapeutic approaches. Collaborate with global teams to design and execute clinical trials. Drive translational medicine strategies in a dynamic environment.Job DescriptionClinical Development Lead OverviewThe 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 & DutiesDesign 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 RequirementsDoctor 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.