Medical Director, Clinical Development

Role: Medical Director, Clinical Development, specializing in oncology for breast cancer therapies, notably palazestrant and OP-3136, in late-stage clinical trials. Responsibilities include providing medical leadership in registration studies, designing clinical protocols, engaging with regulators and investigators, and ensuring scientific rigor and data integrity. The role entails collaboration across functions such as Clinical Operations, Biostatistics, and Safety, with a focus on biomarker development, publication planning, and external scientific communication. Key activities involve oversight of CROs, contributing to regulatory submissions, and supporting data dissemination. Qualifications: MD (US Board Certified) with at least 2+ years biotech/pharma experience in clinical development, particularly in oncology or breast cancer; strong understanding of drug development, GCP, FDA, EMA/CHMP standards; experience as a PI or breast cancer expert is valued. High-value details include focus on ER+/HER2- metastatic breast cancer, pivotal Phase 3 trials, and involvement in biomarker strategies. The position is based in Cambridge, MA, with up to 20% travel. The target candidate is a collaborative, decisive leader with excellent communication skills, adept at cross-functional influence and strategic execution in a fast-paced environment.