Principal Clinical Scientist, Transplant Nephrology

Job Description

HI-Bio, Inc., a Biogen company, is seeking a Principal Clinical Scientist to support clinical research activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to transplantation. This position provides leadership in program development, execution, innovation, and optimization of clinical trials by including the latest insights on disease mechanisms, diagnostic approaches, and alternative therapies. The successful candidate will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve assisting with regulatory documentation by collaborating with discovery, development, and commercial colleagues, as well as managing external collaborations and gaining comprehensive knowledge of the literature related to the product(s) in development. The responsibilities of this role may vary depending on the specific indication and trial requirements.

The Principal Clinical Scientist collaborates closely with Study Physicians/Scientists as a key member of development and core team. The role actively contributes scientific expertise to cross-functional clinical teams involved in the development of novel therapies. As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings. Our ideal candidate will have significant experience in clinical trials for antibodies and can strongly communicate and present relevant clinical data to leadership and core teams.

KEY RESPONSIBILITIES:

• Support the preparation of clinical development plans, trial protocols, case report forms, and study operational plans that are scientifically rigorous, clinically relevant, operationally feasible, while adhering to GCP and regulatory requirements
• Establish and maintain credible relationships with clinical investigators and medical/scientific experts
• Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
• Assist Data Management with the review of clinical data and resolution of queries
• Perform medical monitoring activities and reporting in partnership with Study Responsible Physicians/Scientists, including evaluating clinical trial adverse events and reviewing clinical laboratory results
• Work closely with Quality Management & Assurance to ensure flawless execution of clinical trials
• Draft and coordinate completion of clinical study reports
• Prepare responses to questions from Ethics Committees and Health Authorities
• Support integrated document development for marketing authorization filing
• Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
• Support preparation for FDA Advisory Committee and EU Oral Explanation
• Present relevant clinical …