ObjectiveThe Senior Director, Clinical Development, will provide medical and scientific leadership for oncology clinical trials across pre-clinical through phase 1-4 development. This role requires strong expertise in oncology, radiopharmaceuticals, and clinical drug development to ensure patient safety, scientific rigor, and regulatory compliance across assigned programs.The Senior Director will serve as a medical leader within cross-functional development teams, contributing to clinical strategy, protocol development, and regulatory interactions. This individual will play a critical role in advancing clinical programs toward regulatory approval and supporting future commercialization, while partnering closely with Clinical Operations, Regulatory Affairs, Safety, Translational and other teams as needed.Essential FunctionsMedical Strategy and Clinical OversightProvide medical leadership for assigned oncology clinical programs across pre-clinical through phase 1-4 development.Contribute to the development and execution of clinical and medical strategies aligned with program and company objectives.Oversee patient safety, therapeutic efficacy, and clinical trial data integrity, including identification and mitigation of clinical risks.Ensure compliance with Good Clinical Practice (GCP), ethical standards, and applicable regulatory requirements.Medical Leadership and Scientific ExpertiseServe as the primary medical expert for assigned studies, advising on protocol design, eligibility criteria, endpoints, and safety monitoring and study execution and management. Support regulatory interactions by providing medical input for health authority meetings, briefing documents, and responses to regulatory questions.Review and interpret clinical data to inform internal decision-making and external communications.Mentor and support medical monitors and clinical development team members, contributing to a collaborative and high-performing development environment.Cross-Functional CollaborationPartner closely with Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, and CMC to support efficient trial execution.Contribute to the development, review, and approval of clinical protocols, informed consent forms, clinical study reports, and other key documents.Provide medical input to support dose selection, risk/benefit assessments, and lifecycle planning activities.Regulatory and Corporate ContributionsSupport preparation and review of regulatory submissions, including INDs, amendments, clinical study reports, and safety documentation.Participate in health authority meetings and advisory boards as a medical representative for assigned programs.Asist in data interpretation, clinical presentations, and publications to support regulatory and scientific objectives.Innovation and Industry LeadershipStay at the forefront of advancements in oncology, radiopharmaceuticals, and clinical development methodologies, integrating new scientific and technological innovations into the company’s clinical strategy.Build and maintain relationships with KOLs, academic institutions, and industry consortia to enhance scientific collaboration and drive innovation.Advocate for the company’s vision and therapeutic advancements, positioning the organization as a leader in oncology drug development.Qualifications
