Principal Clinical Scientist, Transplant Nephrology
- Full-time
- Region: US
- Department: Research & Development
HI-Bio, Inc., a Biogen company, is seeking a Principal Clinical Scientist to support clinical research activities for our portfolio of immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to transplantation. 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.
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.
Qualifications:
- PhD/PharmD with 5+ years of industry clinical research experience, preferably in immunology or a related therapeutic area. BS/MS/RN will be considered with additional industry and drug development experience.
- Experience in late-stage drug development, with a preference for experience in immuno-inflammatory indications and/or transplant nephrology.
- Strong analytical skills coupled with communication skills to present findings and relevant data.
- Ability to survey and interpret scientific literature related to assigned projects.
- Strong organizational skills and ability to thrive in a fast-paced startup environment while prioritizing and responding to changing business needs.
- Demonstrated ability to collaborate effectively with cross functional teams and champion and drive solutions for clinical challenges.
- Excellent written and verbal English communication skills.
- Ability to travel domestically and internationally, approximately 10-20% of the time.
This position is Hybrid based and travel to our San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered. For the right candidate, we may be open to remote hires.
HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. Our team in San Francisco is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
The base compensation range for this role is $143,000 - $239,000. Base salary is determined by a combination of factors including, but not limited to, job-related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
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