Senior Medical Director - Clinical Development
July 24
Description
• Reporting to the Vice President of Clinical Development, this is an excellent opportunity for a Sr. Medical Director, Clinical Development physician with experience in oncology clinical development to work within a rapidly growing company. • The Senior Medical Director, Clinical Development is responsible for designing and executing clinical studies, helping to create the clinical development plan for new compounds, and to pave a path towards regulatory approval. • The Nuvalent pipeline is currently focused on development of precision medicines for oncology targets; therefore, the physician will work closely with scientists in discovery research and translational medicine, as well as non-clinical safety, DMPK/clinical pharmacology, biostatistics, clinical operations, data management, pharmacovigilance, and regulatory affairs. • The physician will also lead and participate in teleconferences with academic study investigators, safety review committees, advisory meetings with opinion leaders, and interactions with Health Authorities.
Requirements
• An M.D. or M.D/Ph.D. with experience in oncology is required (subspeciality training in oncology and experience in targeted therapy lung cancer trials preferred). • 4+ years of proven ability in the biotechnology or pharmaceutical industry including direct experience leading high functioning teams. • Thorough understanding of the drug development process from IND through NDA, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations, and pharmacovigilance. • Experience in clinical research, including designing, planning, and monitoring clinical trials. • Experience with high-complexity first-in-human studies is highly desired. • Experience presenting to a variety of audiences including internal teams and external medical/scientific communities. • Experience with interacting with Regulatory Authorities, such as FDA and EMA is preferred. • Ability to travel domestically and internationally to investigator sites and medical meetings, approximately 10%.
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