Lead Clinical Scientist, Transplant

Role Summary

Lead Clinical Scientist, Transplant. Biogen’s West Coast Hub seeks an accomplished and highly motivated Lead Clinical Scientist to provide scientific, strategic, and operational leadership for the organ transplantation clinical development program. Lead the design, execution, and advancement of late-stage clinical trials in antibody-mediated rejection and other organ transplantation conditions. Ensure patient safety, data quality, and scientific integrity throughout the clinical development process with subject matter expertise in solid organ transplantation and strong cross-functional collaboration.

Responsibilities

• Clinical Development Leadership: Help lead the design, execution, and analysis of late-stage organ transplantation clinical studies, ensuring alignment with program strategy while adhering to GCP and regulatory requirements. Develop and refine clinical development plans, study protocols, and other trial-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 patient safety by reviewing adverse events and emerging data; provide real-time medical 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; review clinical trial data for completeness and accuracy; partner with Data Management and Biostatistics to develop data review plans; ensure databases are audit-ready and meet regulatory standards; address enrollment challenges and sustain investigator-site relationships to improve enrollment and retention.
• Cross-Functional & External Collaboration: Lead cross-functional project teams; establish external collaborations with investigators, academic partners, CROs, and other stakeholders; represent Biogen at scientific conferences and meetings; support presentation of clinical data to health authorities.
• Strategic Impact: Anticipate scientific and operational challenges; propose solutions to advance timelines; contribute to portfolio strategy by integrating emerging scientific insights.

Qualifications

• Advanced scientific degree required (MD, PhD, PharmD, or equivalent).
• 6+ years of clinical development experience in biotech/pharma, preferably in organ transplantation.
• Ability to survey and interpret scientific literature related to assigned projects.
• Strong interpersonal and collaboration skills across internal teams and external 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 business needs.
• Willingness to travel domestically and internationally (approximately 30%).

Skills

• Clinical trial design and execution in organ transplantation
• Medical monitoring and safety data review
• Data management collaboration and regulatory filing readiness
• Cross-functional leadership and external collaboration
• Scientific communication and stakeholder education

Education

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