Clinical Program Leader

Provides strategic medical and scientific leadership and expertise to all line functions on the project team for the development of new oncology agents (e.g., small molecules, biologics, radioligand therapies) that are in preclinical development, typically beginning at the PE / DCCreates clinical development strategies for new oncology agents within the PE/ DC to TDP timeframe. The development strategy combines the CPL’s medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy. Delivers solutions within functions, across functions, and on global projects, developing independent approach to TCO strategy. Although registration studies are not within the responsibility of TCO, the CPL must provide an early clinical development strategy that foresees and supports subsequent registration trials. Development of the Integrated Development Plan Approval (IDPA) in alignment with CPL Disease Area Leads (DALs), Development (DEV), Strategy & Growth (S&G), and Commercial teamsLead Biomedical Research Early Program Teams (BPTs) to enable the start of clinical development and continuing through clinical trials needed to support TDP. May lead multiple global project teamsIntegrates preclinical information (pharmacology, toxicology, and pharmacokinetics) and interprets implications for clinical development, as articulated in the Investigator’s Brochure and First-in-Human protocolCollaborates with clinical scientists to develop clinical protocols for TCO compounds and develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports)Applies own medical knowledge to guide the safe, ethical and efficient conduct of the trials under own responsibility. Knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with themLiaises with outside experts, investigators, and regulatory authorities in oncology, and represents own projects to those groups and authoritiesWrites and reviews abstracts/manuscripts etc. for presentation/publications at internal/external meetingsParticipates in task forces to support continuous improvement and other management objectives. Operational responsibility for quality and complianceMay provide informal mentorship to less experienced CPLs