Principal Clinical Scientist, Rare Autoimmune / Nephrology
San Francisco, CA, United States
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 glomerular kidney disease. 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 managing external collaborations and gaining comprehensive knowledge of the literature related to the product(s) in development. Furthermore, responsibilities may include collaborating with Regulatory on document preparation and submission, as well as collaboration with Discovery, Development, and Commercial functions as needed and appropriate. The responsibilities of this role may vary depending on the specific indication and program requirements.
The Principal Clinical Scientist collaborates closely with Study Physicians/Scientists as a key member of the development and study teams. 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 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 …
This job isn't fresh anymore!
Search Fresh JobsJob Profile
401K participation and matching contributions Dental Disability insurances End-of-year shutdown LTI grants LTI grants and other incentive programs Matching contributions Medical Medical, dental, life, long and short-term disability insurances Vacation
Tasks- Assist Data Management
- Collaborate with Clinical Operations
- Execute clinical trials
- Manage external collaborations
- Perform medical monitoring activities
- Prepare regulatory documents
Biostatistics Clinical Development Clinical operations Clinical Research Clinical trials Collaboration Communication Data interpretation GCP Health Authority Submissions Immunology Marketing Medical Monitoring Nephrology Operations Pharmacology Project Management Quality Management Regulatory Submissions
Experience5 years
Education TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9