Principal Clinical Scientist, Rare Autoimmune
5 days ago
Biogen, Inc. is seeking a highly skilled Principal Clinical Scientist to join our team in the development of novel therapies for rare autoimmune diseases. As a key member of our clinical research team, you will be responsible for leading the design, execution, and monitoring of clinical studies evaluating novel therapies across target indications.
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.
This is a hybrid-based position, and the successful candidate will be required to travel to our South San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered. For the right candidate, we may open to remote hires.
Requirements:- MD/PhD/PharmD with 5+ years of industry clinical research experience, preferably in nephrology, immunology, or a related therapeutic area.
- Experience in late-stage drug development, with a preference for experience in nephrology and/or immuno-inflammatory indications.
- Ability to survey and interpret scientific literature related to assigned projects.
- Ability to interface with health authorities and represent clinical programs with integrity, polish, and professionalism.
- Ability to travel domestically and internationally, approximately 10-20% of the time.
Biogen, Inc. offers a competitive compensation package, including a base salary range of $143,000 - $239,000, as well as opportunities for professional growth and development. We are an equal opportunity employer and welcome applications from diverse candidates.
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