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

About This Role

Make the most meaningful impact of your career in this rewarding role with HI-Bio, Inc., a Biogen company. As a Clinical Trial Manager you will design operational strategy and oversee our clinical research organization (CRO) partners to provide operational input into the development of clear protocol concepts and final protocols. You will own or share responsibility for entire clinical trial studies, including operational design, successful delivery, and the positive impact on the lives of patients with a wide array of immune-mediated diseases. 

This is a hybrid (part-time on-campus) opportunity, with full-time remote work considered.

What You’ll Do

• Independently or in conjunction with other study Clinical Trial Leads, develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
• Chair the Clinical Study Team (CST) meeting to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
• Provide operational guidance to sites, CRO and other key suppliers
• Provide operational oversight of clinical study suppliers
• Strategize and coordinate efforts with study start up including site feasibility, site selection, and distribution of regulatory packets
• Attend scientific meetings
• Strategize and coordinate efforts to ensure completeness of eTMF
• Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
• Manage budget, approve invoices and participate in the monthly accrual process
• Participate in the testing of clinical study systems including IRT and EDC
• Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.
• Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation.
• Ensure effective, consistent, efficient and compliant processes.

Who You Are

Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.

This position is a Hybrid role requiring travel into our South San Francisco offices on a regular basis. For the right candidate we are open to hiring remote-US with a preference for West Coast talent. 

Qualifications

Required Skills & Experience 

• Bachelor's degree in a scientific discipline with 5+ years of professional work experience in the life sciences
• 3+ years in clinical operations management, overseeing outsourced clinical trials per quality, timeline, and budget expectations, preferably with a sponsor company and a CRO
• Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills
• Extensive knowledge of clinical development related to one or more trial phases (I, II, III, or IV), as well as cross-functional drug development
• Unquestioned expertise in Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines and regulatory requirements for clinical development
• Ability to establish operational plans and support the CRO in executing them
• Effective CRO management skills and ability to adapt to the Global Clinical Operations (GCO) outsourcing model

Preferred Experience

• Sponsor and/or CRO Global trial management experience
• Investigator site and/or monitoring experience

Additional Information

The base compensation range for this role is $107,000 - $173,000. 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.