Clinical Development Lead, Transplantation

Role Summary

Clinical Development Lead, Transplantation is a senior role within Biogen’s West Coast Hub focused on supporting clinical development activities for the organ transplant portfolio. The role involves designing, executing, monitoring, interpreting, and reporting clinical studies evaluating novel therapies across organ transplantation, with extensive cross-functional collaboration and regulatory engagement.

Responsibilities

• Lead medical and scientific oversight of organ transplantation clinical trials, including protocol design, study monitoring, safety review, and data analysis ensuring alignment with strategic objectives and timelines while adhering to GCP and regulatory requirements
• Provide clinical expertise in nephrology and transplantation
• Communicate with investigators to address study conduct and enrollment at study sites
• Collaborate with Clinical Operations in trial setup, site engagement, recruitment, retention strategies, closeout, and reporting
• Partner with data management and biostatistics in data review, query resolution, and ensuring high-quality datasets for regulatory filings
• Prepare and contribute to clinical study reports, regulatory submissions, and responses to Ethics Committees and Health Authorities
• Provide clinical leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarkers, regulatory affairs, medical writing, and others
• Establish and maintain trusted collaborations with key opinion leaders and clinical investigators in the transplantation field and disease areas related to clinical development programs
• Ensure compliance with regulatory requirements and guidelines
• Represent Biogen externally at scientific conferences, investigator meetings, and other industry events

Qualifications

• US board-certified transplant nephrologist (MD or equivalent)
• 3+ years of clinical development experience in the pharmaceutical or biotechnology industry or equivalent
• Team player with significant clinical experience managing patients with organ transplants
• Knowledge of clinical trial design and execution, patient recruitment, and outcomes in transplant populations
• Understanding of regulatory requirements for drug development, including experience leading interactions with global regulatory agencies
• Ability to analyze and communicate complex data from transplant clinical trials
• Excellent interpersonal skills, with the ability to establish and maintain relationships with key opinion leaders, clinical investigators, and internal stakeholders through a highly collaborative approach
• Strong written and verbal communication skills; ability to present clinical insights to leadership and external stakeholders
• Ability to travel domestically and internationally, approximately 30% of the time