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Senior Clinical Research Scientist, Transplant Immunology
2 months ago
We are seeking a highly skilled Principal Clinical Scientist to join our team at Biogen, a global leader in the development of innovative therapies for severe immune-mediated diseases. As a key member of our clinical development team, you will play a critical role in the design, execution, and monitoring of clinical studies evaluating novel therapies across target indications.
Key Responsibilities- Program Development and Execution: Collaborate with cross-functional teams to develop and execute clinical development plans, trial protocols, and study operational plans that meet scientific, clinical, and regulatory requirements.
- Clinical Trial Management: Establish and maintain relationships with clinical investigators and medical/scientific experts, and collaborate with Clinical Operations to ensure seamless trial setup, conduct, recruitment, and closeout.
- Data Management and Analysis: Assist Data Management with the review of clinical data, resolution of queries, and performance of medical monitoring activities and reporting.
- Regulatory Compliance: Ensure compliance with GCP and regulatory requirements, and collaborate with Quality Management & Assurance to ensure flawless execution of clinical trials.
- Document Development and Submission: Draft and coordinate completion of clinical study reports, and prepare responses to questions from Ethics Committees and Health Authorities.
- Communication and Presentation: Present relevant clinical data to internal and external stakeholders, and collaborate with senior clinical personnel to prepare oral and written results of product research for health authority submissions.
- Education and Experience: MD/PhD/PharmD with 5+ years of industry clinical research experience, preferably in immunology or a related therapeutic area.
- Therapeutic Area Expertise: Experience in late-stage drug development, with a preference for experience in immuno-inflammatory indications and/or transplant nephrology.
- Analytical and Communication Skills: Strong analytical skills coupled with excellent communication skills to present findings and relevant data.
- Collaboration and Leadership: Ability to collaborate effectively with cross-functional teams and champion and drive solutions for clinical challenges.
- Travel and Work Environment: Ability to travel domestically and internationally, approximately 10-20% of the time, and work in a hybrid environment with regular travel to our San Francisco office.
