Manager, Biosample Operations
Mountain View, CA /
Clinical Research & Development – Clinical Biomarkers/Clinical Biosample Operations /
/ Hybrid
About IGM Biosciences, Inc.
IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases, and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology, and inflammation targets. For more information, please visit www.igmbio.com.
IgM Antibodies and Autoimmune and Inflammatory Diseases
Antibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases, and IgMs are the first antibody defense against a pathogen infection. We are committed to exploring how the unique structure and binding properties of our IgM platform can improve outcomes for patients with these serious conditions.
IgM Antibodies and Oncology
IGM Biosciences has a T cell engager program, a receptor cross-linking agonist program and a targeted cytokine program in clinical studies for the treatment of patients with solid tumors and hematological malignancies.
Responsibilities:
· Develop and maintain effective, collaborative relationships with Clinical Study Teams, internal outsourcing contacts, CROs, and other key stakeholders.
· Responsible for assessing feasibility for biomarker operations plans on clinical studies across related functions.
· Leads the development and finalization of the Biomarker Management Plan (BMP) based on input from relevant scientific and operational teams.
· Establish study-specific biosample analysis and data management plan with key stakeholders.
· Manage the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data transfer, and final sample disposition, in accordance to study protocol and under the highest standards of quality, ethics, and informed consent.
· Facilitate resolution of sample and data discrepancies. Provide biosample metrics and status updates to teams as requested.
· Provide input, including authorship/review of relevant sections, to study related documents (i.e., protocols/ICFs, feasibility questionnaires, central lab SOWs, clinical site laboratory manuals, SOPs, assay performance and bioanalytical reports, etc.).
· Apply appropriate regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation).
· Conduct technical audits of vendors as needed.
· Proactively identify areas of best practice and process improvements.
Qualifications:
· Life sciences degree (BS or MS) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
· 5+ years of experience related to clinical biosample handling, analysis, and CRO management in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
· Experience with clinical study operations teams and working knowledge of ICH GCP, GLP, regulatory compliance and FDA standards.
· Demonstrated technical experience/knowledge of bioanalytical assay methods related to cancer immunotherapy, T cell engagers, and antibody-based therapeutics is preferred.
· Proven ability to efficiently and effectively manage multiple competing priorities and deliver results successfully.
· Highly organized, detail-oriented, and self-motivated; strong communicator and collaborator, with effective influencing/negotiating skills.
· Strategic and critical thinker who exercises independent judgment to identify and solve problems as well as make decisions.
We offer a fast-paced, collaborative, team-based, work environment.
One of our top priorities is to maintain the health and well-being of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:
· Medical, dental and vision insurance.
· The full premium amount for our employees and their dependents is covered by IGM
· FSA (Flexible Spending Account)
· STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
· 401(k) Plan
· 120 hours of Paid Time Off, 5 sick days per year, 11 holidays
· Cell phone & internet subsidy
· Employee Referral Bonus Program
· Annual training budget for professional development
· Commuter Benefit
· Annual bonus program
· New hire stock options
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.
