The Opportunity:

Relay Therapeutics seeks a motivated and patient-centric VP, Late Development Medical Leader who is looking to have a broad and tangible impact on small molecule drug development. Reporting into the SVP, Head of Clinical Development, this highly critical role will provide medical leadership to RLY-4008, a highly selective FGFR2 late stage clinical asset in pivotal development, and will lead the NDA submission and FDA interactions from a medical perspective. This is an opportunity to help build a world-class development organization at a revolutionary biotech and make a significant impact on patients. 

Your Role:

• Develop and drive strategic registration plans and oversee NDA medical submission activities, in conjunction with other relevant functional leaders 
• Oversee all medical aspects of regulatory interactions and submission activities for RLY-4008
• Lead the late clinical development medical team to execute and achieve functional responsibilities and program goals in compliance with GCP, ICH, and other global regulatory requirements
• Generate/review clinical components of key documents in support of regulatory submissions, including clinical sections of NDA
• Co-author and ensure quality of all NDA clinical documents (e.g., CSRs, Integrated Safety Summary, Integrated Efficacy Summary, Clinical Overview)
• Analyze and interpret data expertly, and clearly communicate results both internally and externally

Your Background:

• You have earned an MD or MD/PhD with oncology experience in early and late stage clinical trials
• You know what successful small molecule development looks like and you bring 5+ years of industry experience
• You have experience in authoring and reviewing clinical study documents in support of regulatory submissions, in support of major regulatory submissions (eg, NDA, BLA)
• Advanced knowledge and experience in Late Development Oncology, ranging from protocol design - through execution of pivotal registration oncology studies
• You have excellent leadership skills and proven ability to effectively work in a cross-functional/matrix environment