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Principal Research Scientist, Immunology Clinical Development
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: Provide leadership in the development and execution of clinical research programs, including the design, execution, and monitoring of clinical studies.
- Scientific Expertise: Collaborate with cross-functional teams to provide scientific expertise and support the development of novel therapies.
- Regulatory Documentation: Assist with the preparation of regulatory documents, including clinical study reports and regulatory filings.
- Collaboration and Communication: Establish and maintain credible relationships with clinical investigators, medical/scientific experts, and other stakeholders.
- Data Management and Analysis: Collaborate with Data Management to review clinical data and resolve queries.
- Medical Monitoring and Reporting: Perform medical monitoring activities and reporting in partnership with Study Responsible Physicians/Scientists.
- Quality Assurance: Work closely with Quality Management & Assurance to ensure flawless execution of clinical trials.
- Document Development: Draft and coordinate completion of clinical study reports and other regulatory documents.
- Stakeholder Engagement: Present relevant clinical data to internal and external stakeholders, including health authorities and regulatory agencies.
- Education: MD/PhD/PharmD with 5+ years of industry clinical research experience, preferably in immunology or a related therapeutic area.
- Experience: Experience in late-stage drug development, with a preference for experience in immuno-inflammatory indications and/or transplant nephrology.
- Skills: Strong analytical skills, excellent communication skills, and ability to survey and interpret scientific literature related to assigned projects.
- Collaboration and Leadership: Demonstrated ability to collaborate effectively with cross-functional teams and champion and drive solutions for clinical challenges.
- Travel: Ability to travel domestically and internationally, approximately 10-20% of the time.
Biogen is a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission: Caring Deeply, Achieving Excellence, Changing Lives.
