About This Role

This role is responsible for clinical study bioanalytical and biomarker operations management. The bioanalytical and biomarkers study manger 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 data is part of primary and secondary study endpoints and contributes to driving programs forward in the drug development process. The Biomarkers study manger reports to the Associate Director of study management within the Biomarkers department.

What You’ll Do

• Represent Biomarkers and Bioanalytical functions on cross functional clinical study management teams
• Lead operational support for collection and testing of clinical patient samples in support of clinical study protocols
• Collaborate with multiple functional representatives to gather protocol input
• Obtain contracts and work within the contracting process for execution of assay development, validation and sample testing needs
• Meet with vendors regularly and oversee the completion of deliverables

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.  

Required Skills 

• Bachelor’s degree in a biological science or related technical field and 10+ years of industry experience
• Experience working within GCP, GLP, & GCLP guidelines 
• 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

Preferred Skills

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

The base compensation range for this role is $122k-$197k. 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.  This person will support EST hours M-F 9am-5pm.

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.