Lead Clinical Scientist, Transplant

Role Summary

Lead Clinical Scientist to provide scientific, strategic, and operational leadership for organ transplantation clinical development, guiding the design, execution, and advancement of late-stage clinical trials in antibody-mediated rejection and related transplant conditions. Ensure patient safety, data quality, and scientific integrity across the clinical development process, with subject matter expertise in solid organ transplantation, oversight of global trials, and strong cross-functional collaboration.

Responsibilities

• Clinical Development Leadership: Help design, execute, and analyze late-stage organ transplantation studies, ensuring alignment with program strategy and adherence to GCP and regulatory requirements. Develop and refine clinical development plans, study protocols, and related documents.
• Medical Oversight: Provide medical and scientific oversight of clinical trials; implement study-specific medical monitoring plans; review patient eligibility, safety data, and protocol adherence; monitor safety via adverse events and lab results; provide real-time guidance to investigators; participate in Data Monitoring Committees, adjudication committees, and safety review meetings as required.
• Data Quality & Integrity, Enrollment and Retention: Support case report form design; conduct ongoing data review and query resolution; collaborate with Data Management and Biostatistics on data review plans; ensure databases are clean and audit-ready; address enrollment challenges; build investigator relationships and implement strategies to improve enrollment and retention.
• Cross-Functional & External Collaboration: Lead cross-functional teams with clinical operations, biometrics, regulatory affairs, biomarkers, clinical pharmacology, and medical writing; establish external collaborations with investigators, academic partners, CROs; represent Biogen at conferences and advisory boards; assist with presenting clinical data to health authorities.
• Strategic Impact: Anticipate scientific and operational challenges, proposing solutions to accelerate timelines; contribute to portfolio strategy by integrating emerging insights and competitive intelligence.

Qualifications

• Advanced scientific degree required (MD, PhD, PharmD, or equivalent)
• 6+ years of clinical development experience in biotechnology or pharmaceutical industry, preferably in organ transplantation
• Ability to survey and interpret scientific literature related to assigned projects
• Strong interpersonal skills and ability to collaborate across internal teams and external clinical partners
• Strong analytical skills with excellent oral and written communication to present findings and influence senior stakeholders
• Strong organizational skills and ability to thrive in a fast-paced environment with changing priorities
• Willingness to travel domestically and internationally (approximately 30%)

Education

• Advanced scientific degree required (MD, PhD, PharmD, or equivalent)