Education: *MD or DO degree required; *Board-certification in Hematology-Oncology
Required Experience: *5-10 years pharma/biotech industry experience in oncology clinical trials and the equivalent term experience in an academic setting. In case of no industry experience, substantially longer academic experience in translational oncology and substantial clinical study experience *Interpretation of preclinical data in hematology/oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology) *Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials *Proven ability to analyze and interpret efficacy and safety data relating to oncology *Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology
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1 purpose...to reimagine medicine! NIBR is seeking a board-certified (or equivalent) Hematologist-Oncologist to lead hematology strategy in Translational Clinical Oncology (TCO) in collaboration with colleagues in the Global Development Organization and Oncology research. This is a very exciting opportunity to join TCO.
Role Purpose: To provide strategic medical guidance for and lead the development of multiple experimental heme-onc agents in the TCO portfolio, beginning with input to early Target identification and continuing through to the Development Decision Point. Provide strategic guidance to the heme-onc research portfolio and formulate actionable development plans with the Global Development Organization to ensure rapid and seamless decision making and transitions of molecules in the heme-onc portfolio.
Major Responsibilities: *Oversee and implement clinical strategy of multiple molecules that are advancing to clinical testing ensuring that robust and comprehensive development plans are in place and implemented. *Responsible for high quality documents for programs and studies under supervision including but not limited to protocol, IBs, and health authority responses *Provide senior leadership and clinical input to clinical studies under his or her responsibility. Provide leadership to effectively integrate your medical knowledge with expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy *Lead Early Program Teams (EPT) for 1-2 program studies beginning at approval to conduct GLP toxicology studies to enable the start of clinical development, defining strategies for Proof-of-Concept and development decision points. Provide oversight to direct reports who are leading EPTs *Provide early clinical development strategy that foresees and supports subsequent registration trials by working closely across the organization. *Oversee external collaborations partnering with associates from research, project management, and strategic alliance including leadership in steering committee oversight *Play leadership roles in early and late development committees and initiatives such as Target ID and Validation and Disease Area strategies by actively contributing strategic advice and to the decision making process and internal committees such as the protocol review committee (PRC). *Apply medical knowledge to guide the safe, ethical and efficient conduct of own trials. Strives to maintain or exceed compliance obligations for Good Clinical Practice guidelines and Novartis Standard Operating Procedures *Liaise with outside experts, investigators, and regulatory authorities in Hematology-Oncology and represents projects to those groups and authorities *Write and review abstracts/manuscripts, etc. for presentation/publications at internal/external meetings.
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