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Senior Clinical Research Scientist

2 months ago

South San Francisco California, United States Biogen Full time
Job Summary

Biogen is seeking a highly experienced Principal Clinical Scientist to support clinical research activities for our portfolio of immunology clinical programs. The successful candidate will provide leadership in program development, execution, innovation, and optimization of clinical trials by incorporating the latest insights on disease mechanisms, diagnostic approaches, and alternative therapies.

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 data to internal and external stakeholders.
  • Review medical literature and related new technologies relevant to the assigned projects.
Requirements
  • Experience with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications.
  • Ability to excel in a fast-paced environment and collaborate cross-functionally with discovery, development, and commercial colleagues.