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 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.
• Other responsibilities may include utilizing nonclinical PK and PK/PD data (including use of modeling and simulation techniques) to project optimal clinical dosing regimens, doses based on pharmacological/clinical targets, human starting doses, and biomarker exploratory data (including biochemical and molecular data from quantification of mRNA, multi-panel flow cytometry, and protein expression)
• Evaluate and implement necessary tools and systems to organize and analyze data
• Conduct clinical studies with utmost integrity, professionalism, and organization

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 open to remote hires.

Qualifications

Qualifications

• 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
• 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 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.

[BS1]Do we wish to revise this and make it more open-ended?

Additional Information

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. As part of a mid-sized biotechnology company, we offer 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.

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.

Why Biogen?

We are 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.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.