Chief Medical Officer(CMO) - Oncology Focus

We are seeking a highly accomplished, board-certified physician-leader to serve as Chief Medical Officer (CMO). This pivotal role requires a specialist in medical oncology with deep experience in early- and mid-stage clinical development (Phase 1-3) of antibody therapeutics, targeting solid tumors, particularly lung cancer. As a key member of the leadership team, the CMO will define and execute the company’s global clinical and regulatory strategy, provide medical oversight of development programs, and build the internal clinical, regulatory, and safety infrastructure from the ground up. Key Responsibilities: 1. Clinical Development Leadership - Lead the end-to-end clinical development strategy for our portfolio, with immediate focus on IND submission and initiation of global Phase 1 oncology trials. - Provide medical and scientific leadership for protocol design, Investigator Brochures, clinical study reports, and data interpretation across all phases of development. - Serve as the primary medical authority ensuring programs meet Good Clinical Practice (GCP), ICH E6(R2), and global regulatory standards. - Guide strategic decisions on study design, patient selection, biomarkers, and translational endpoints for degrading antibody therapeutics in solid tumors. 2. Regulatory Strategy and Agency Engagement - Provide strategic and hands-on leadership for regulatory activities, including pre-IND interactions, IND/CTA submissions, and ongoing communication with FDA, EMA and other health authorities. - Initially, oversee external regulatory consultants supporting submissions and compliance; play a key role in establishing the internal Regulatory Affairs function as the company grows. - Represent the company’s medical and clinical perspective in meetings with regulators, ensuring alignment of regulatory, clinical and CMC strategies. - Partner with CMC and Technical Operations teams to ensure clinical supply readiness and alignment with investigational product quality. 3. Safety and Pharmacovigilance Oversight - Provide executive medical oversight of safety strategy, risk management, and signal evaluation. - Ensure that robust pharmacovigilance processes are in place and compliant with global regulations, collaborating with internal and external safety experts. - Serve as the senior medical reviewer for serious adverse event assessments and clinical safety decisions. 4. Organizational Leadership and Operations - Build and lead a high-performing clinical organization, including Clinical Operations, Regulatory Affairs, Safety/PV, and Data Management. - Recruit, mentor, and develop internal clinical and scientific talent to support the company’s growth and transition into later-stage development. - Provide executive oversight of the clinical development budget, ensuring alignment of resources and vendor partnerships (CROs, labs, consultants) with strategic priorities. - Foster a culture of scientific rigor, accountability, and cross-functional collaboration.