Company Description

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.

Job Description

HI-Bio, Inc., a Biogen company, is seeking a Clinical Trial Specialist (CTS) or Senior CTS  to assist in the execution of Clinical Trials. The successful candidate will be able to support the conduct of clinical trials with minimal guidance/supervision while ensuring alignment with GCP and HI-Bio’s SOPs. The Specialist provides a high level of administration, coordination and organizational support to the Clinical Study Lead and team members from all functions involved in assigned study(ies). The role requires an ability to manage multiple priorities consecutively and priorities consecutively and sequentially and meeting quality standards for accuracy, attention to detail and timelines. As part of a growing clinical development operations team, the Specialist will help define various aspects of clinical trials to ensure timely completion, efficient protocols, budget alignment, and compliance with ICH/GCP Guidelines.

The role reports to the Head of Development Operations. Level will be commensurate with experience.

KEY RESPONSIBILITIES:

• Overall global tracking of study deliverables with escalation of key issues/trends.
• Support and/or manage protocol related site/supplier activities.
• Assist and/or manage in the design, format, review and content of study guides, worksheets, quick reference cards and other materials/documents used to support the study.
• Contribute to protocol review and amendment management, including informed consent initiation and updates.
• Attend, contribute and potentially lead supplier meetings; work with suppliers to resolve issues, and foster process improvements.
• Monitor progress of studies, help identify study related trends/issues and work with Clinical Trial Managers (CTM) to implement corrective actions when necessary.
• Submission of documents to TMF and assist with TMF reconciliation as needed.
• Oversee study start-up activity tracking with CTM oversight
• Assist tracking study milestones in tools and dashboards.
• Point of contact (as delegated) for study related issues.
• Contribute to the development of recruitment strategies and materials; assist with external recruitment activities and supplier management.
• Work with sample management to coordinate shipment and analysis of sample needs; lead reconciliation efforts.
• Support and contribute to Inspection Readiness processes.
• May participate in cross-functional study management activities and process improvement initiatives.
• Lead Site Management Oversight tasks to ensure CRO activities are being completed per the Monitoring Plan.
• Contribute to protocol review, content and ICF development.
• Some travel may be required (<30%).

This position is open to remote talent in the United States with a strong preference for East Coast (EST) talent.

Qualifications

• Combination of degree and relevant Biopharma related experience within a pharmaceutical, biotech environment in a Clinical Operations function/role.
  • Bachelor’s degree and 3 years of direct related experience
  • OR Associates degree and 5 years of direct related experience
  • OR High school diploma or equivalent and 6 years of direct related experience
• Ability to manage multiple priorities and allocate tasks efficiently to keep trials on track
• Experience in a small company or immunology is a plus
• Current knowledge of ICH, GCP, and other regulatory guidelines
• Ability to think critically and solve problems, possesses a quick and analytical mind, is a fast‑learner and works well in an organization that places a high value on intellectual capacity
• Strong attention to detail and an ability to identify gaps and innovate solutions
• Excellent written and verbal communication and a highly motivated disposition

Additional Information

The base compensation range for this role is $80,000-$120,000 for CTS and $84,000 - $127,000.00 for Sr CTS. 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.