About the job

Find out more about this role by reading the information below, then apply to be considered. Chief Medical & Regulatory Officer (CMO) | Boston, MA Location: Boston, MA (Hybrid) Function: Executive Leadership – Clinical & Regulatory Strategy Employment Type: Full‐time About the Company: Our client is a fast-growing biotech based in Boston, advancing transformative therapies in oncology, rare diseases, immunology, and precision medicine. We are pioneering first‐in-class molecules, biologics, and advanced modalities, and are committed to accelerating regulatory approval pathways to bring therapies to patients quickly. Role Overview: We are seeking a Chief Medical & Regulatory Officer (CMO) to join our executive team. This role combines clinical leadership with regulatory strategy oversight, providing a unique opportunity to lead the interface between development programs and global health authorities. The CMO will drive regulatory planning, clinical program design, and lifecycle management, ensuring alignment from IND through NDA/BLA approvals. Key Responsibilities: Develop and execute global regulatory strategy in partnership with clinical, safety, and CMC teams Serve as the primary FDA, EMA, and Health Authority liaison, including Pre‐IND, End-of-Phase, and advisory committee interactions Lead clinical trial design with regulatory and strategic alignment for first-in-class, rare disease, and breakthrough therapies Provide guidance on Orphan Drug, Fast Track, Breakthrough Therapy, and pediatric designations Oversee regulatory submissions (INDs, NDAs, BLAs, CTAs) and maintain compliance with global regulations Mentor and scale cross-functional regulatory and clinical teams Represent the company to external stakeholders, investors, and advisory boards on regulatory strategy and risk mitigation Qualifications: MD, DO, or equivalent clinical degree; advanced regulatory certification preferred (RAC, regulatory affairs background) 15+ years of combined clinical and regulatory leadership experience in biotech/pharma Proven xsgimln success navigating FDA, EMA, and global regulatory pathways from early to late-stage development Experience with Orphan Drug, Breakthrough, Fast Track, pediatric, and lifecycle management Strong background in oncology, rare disease, or immunology is highly desirable Demonstrated ability to lead cross-functional teams and communicate effectively with executive leadership Why Join Us: Lead regulatory and clinical strategy at a well-funded, innovative biotech Influence high-impact programs targeting unmet medical needs Drive global regulatory approvals and accelerate patient access Competitive executive compensation, equity, and benefits