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Clinical Program Leader / Director (MD / DO)


Executive Director


Cambridge, Massachusetts, United States

6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.<br><br>As the Clinical Program Leader (CPL) / Director (MD / DO), you will provide strategic medical guidance and lead the development of experimental oncology agents in the Translational Clinical Oncology (TCO) portfolio, beginning with the candidate selection phase of preclinical development and continuing through clinical proof-of-concept. <br><br>Your key responsibilities:<br>Your responsibilities include, but are not limited to:<br>• Lead the Early Program Team (EPT), report to Clinical Site Head<br>• Build a clinical development strategy for new oncology agents that are within the candidate selection to proof-of-concept (PoC) timeframe. The development strategy combines the CPL’s medical knowledge with the expertise of colleagues in a wide range of other fields (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy.<br>• Provide an early clinical development strategy that foresees and supports registration trials<br>• Lead the EPTs, from time of approval to conduct Good Laboratory Practices toxicology studies to enable the start of clinical development through those clinical trials needed to demonstrate PoC.<br>• Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator’s Brochure and first-in-human protocol.<br>• Collaborate with clinical scientists to develop protocols for TCO compounds and to develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports).<br>• Apply medical knowledge to guide the safe, ethical and efficient conduct of the trials under their responsibility. Be knowledgeable in Good Clinical Practice (GCP) guidelines and Novartis Standard Operating Procedures and strive to maintain compliance with them.<br>• Liaise with outside specialists, investigators, and regulatory authorities in the field of oncology, and represents their projects to those groups and authorities.<br>• Write and review abstracts/manuscripts, etc. for presentation/publications at internal/external meetings.<br>• Participate in task forces to support continuous improvement and other management objectives.<br><br>This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will not require travel as defined by the business (domestic and/ or international).<br><br>[#video#{#400,300#}#/video#]