Senior Manager, Biomarker Operations

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

HI-Bio, Inc., a Biogen company is seeking an experienced Biomarker Operations Senior Manager to oversee clinical study bioanalytical and biomarker operations. The Biomarker Operations Senior Manager is a member of the clinical study team and will contribute to study start up, sample testing, data delivery and CRO management as it relates directly to supporting the PK, ADA and Biomarkers components of study, program and corporate timelines. This pivotal role requires an individual who can integrate scientific and operational expertise, ensuring the successful delivery of biomarker and bioanalytical initiatives through effective cross-functional collaboration. This role reports to the head of Bioanalytical Development and Operations.

What You’ll Do

• Drive the implementation and execution of clinical biomarker and bioanalytical plans for early and late-stage programs
• Lead operational support for collection and testing of clinical patient samples in support of clinical study protocols
• Lead the development of the clinical study biomarker and bioanalytical biosample collection, processing, and storage strategies
• Review study-specific documents, including study protocols and informed consent forms (ICFs), providing input on sample collection, handling, analysis, transport, and storage
• Work closely with data management and bioanalytical leads to establish data collection and transfer specifications with testing vendors and central/specialty labs
• Ensure that data received is consistent with the collection and assay plan and protocols.
• Obtain contracts and work within the contracting process for execution of assay development, validation and sample testing needs
• Manage relationships with internal and external partners to ensure on-time and quality deliverables
• Represent Biomarkers and Bioanalytical functions on cross functional clinical study management teams
• Lead process improvement projects to enable efficiency and innovation
• Performs work independently under the general guidance of the supervisor

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.

Qualifications

Who You Are

You thrive in a fast-paced clinical development environment focused on bringing new therapies to patients. Your knowledge of scientific operations, GCLP and CRO management brings the ability to work within the both the internal teams and contracted lab environments. 

• Bachelor’s degree in a biological science or related technical field and 10+ years of industry experience
• Good knowledge of phase I-III clinical study operations as it pertains to specialty testing (PK, ADA, Biomarkers)
• Experience working with contracted central labs and biomarker/bioanalytical testing labs including sample management, data management, testing requirements and timelines
• Experience reviewing clinical protocols and ICFs
• Experience obtaining contracts and an understanding of Master Agreements and associated contracts
• Experience working within GCP, GLP, & GCLP guidelines
• Must be very organized and have the ability to manage multiple projects at a time

Preferred Skills

• Basic understanding of biological assay methodologies, plate based, flow cytometry, genetic, etc.

Additional Information

The base compensation range for this role is $135,500 - $196,500. 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.