Biomarker Program Manager III

Position Title: Biomarker Program Manager III

Work Location: North Chicago, Waltham, South San Francisco - Hybrid Onsite (Can be any of those 3 locations)

Assignment Duration: 2+ Years

Work Arrangement: Hybrid Onsite

Position Summary: The role is for a Biomarker Program Manager III supporting precision medicine biomarkers and clinical studies. The team works across different areas within the company, not only within Precision Medicine, and interacts with multiple internal groups and external vendors.

Background & Context: The position specifically supports the oncology therapeutic area, which has approximately 15 people; across all therapeutic areas, the team has approximately 30 people. The Biomarker Program Manager works closely with the biomarker lead within Precision Medicine and manages the logistics associated with clinical-trial samples and documentation.

Key Responsibilities: * Managing biomarker samples collected from clinical studies * Coordinating sample analysis with external vendors * Managing vendor agreements * Maintaining study enrollment and sample inventory * Supporting clinical-trial documentation * Handling financial forecasting related to vendor invoices

Qualification & Experience: * Previous biomarker program management experience is the primary preferred background, ideally at another company at the BPM3 level * Familiarity with precision medicine biomarkers, including understanding the concept of analyzing biomarkers for precision medicine clinical studies * Candidates should be familiar with clinical studies, including protocol development, lab specification documentation, central lab SOWs, and ICFs (Informed Consent Forms). Familiarity with this documentation is imperative * Strong proficiency in Excel and PowerPoint is required * Experience interacting with external vendors is important. The role includes managing vendor agreements, ensuring vendors perform according to agreements, confirming invoices align with agreements and services rendered, receiving analyzed-sample data, and approving invoices after the biomarker lead verifies the data * Experience with study enrollment and maintaining study-enrollment information is important * Experience maintaining sample inventory/sample trackers is important * Candidates should understand financial forecasting, including forecasting when vendor invoices are expected and how much they will be based on the samples/services being analyzed * Clinical development and operations experience can also be relevant * Preferred background order: Biomarker Program Management Clinical Translational Sample Operations * Oncology is the preferred therapeutic-area background. Candidates with precision medicine biomarker experience in neuroscience or immunology can also be considered * Relevant experience can come from CRO or academic settings if the candidate has performed comparable work, such as ACTA/HPLC work, fractionation, or chromatography. The experience should be related to biologics or pharmaceutical biologics * A strong understanding of protein structure and post-translational modifications is important and is a great plus * Capillary electrophoresis experience is a nice-to-have. Experience closer to CESDS or ICIF is preferred; CZE is not a requirement * Mentoring experience is not required * There is no specific certification requirement * Soul Tracks and TrackWise are systems in play, but exact experience with these tools is not required because there will be a training component * Candidates with higher levels of experience can be considered; there is no overqualification concern based solely on years of experience. However, the candidate should understand that this remains a BPM3-level role * A candidate with an MD, PhD, bachelor's, master's, associate's, or MBBS/medical-doctorate-equivalent background can be considered depending on the candidate's relevant experience and fit * Candidates should be comfortable working onsite at one of the three locations; 100% remote is not an option