Barrington James
Senior Medical Director, Clinical Development (Oncology) Location: US Remote A global, innovation-driven biopharmaceutical company is seeking a Senior Medical Director of Clinical Development to support the advancement of a broad clinical pipeline focused on oncology. With a robust portfolio of approved and late-stage assets, this company is committed to developing high-quality and accessible biologics for patients worldwide. Position Overview:Reporting directly to the Chief Medical Officer, the Senior Medical Director will lead clinical development strategy and execution for a portfolio of clinical-stage programs. This individual will oversee medical aspects of clinical trials from design to regulatory submission, providing scientific and operational leadership in close collaboration with cross-functional stakeholders. The role includes responsibility for global trial oversight, medical monitoring, regulatory engagement, and team leadership.Key Responsibilities Clinical Development Strategy & Leadership Serve as the Clinical Development Lead, providing strategic and operational direction for ongoing clinical trials. Line manage a team of 2 Associate Directors and 1 Medica Director Lead the design, execution, and oversight of clinical development plans and trial protocols. Represent the company in scientific forums, investigator meetings, and global regulatory interactions. Cross-Functional Collaboration Partner closely with Clinical Operations, Regulatory Affairs, Program Management, CMC, and external CROs to ensure alignment across all trial activities. Lead and mentor a team of clinical scientists and medical staff to achieve development objectives. Trial Oversight & Execution Ensure medical governance and ethical compliance across all studies, with accountability for clinical deliverables. Drive site and investigator engagement, patient recruitment strategies, and data interpretation. Oversee the drafting and review of key clinical documents, including protocols, IBs, CSRs, and regulatory submissions. Regulatory & Safety Responsibilities Operate as a central point of contact for medical oversight and safety risk mitigation across studies. Ensure adherence to ICH-GCP guidelines and regulatory compliance across all development phases. Participate in regulatory authority meetings and contribute to the preparation of submission materials (e.g., INDs, NDAs, etc.). External Engagement & Representation Build and maintain strong relationships with key opinion leaders (KOLs), investigators, and external collaborators. Engage in external conferences, advisory boards, and scientific exchange. Qualifications Required: MD with Board Certification in Oncology (preferred) or strong Oncology background. Minimum of 8 years' experience in clinical development within the biotech or pharmaceutical industry. At least 5 years of line management leadership experience managing clinical or medical affairs teams. Demonstrated track record in leading global clinical trials and progressing programs through regulatory milestones. Deep understanding of GCP, ICH guidelines, regulatory frameworks (FDA, EMA), and clinical trial operations. Strong scientific acumen with the ability to interpret, synthesize, and communicate complex clinical data. Preferred: Experience in thoracic oncology. Previous involvement in regulatory submissions and interactions with global health authorities. #LI-OG1