Clinical Biomarker Lead
3 weeks ago
We are seeking a highly skilled Clinical Biomarker Lead to join our team at BioSpace, Inc. The successful candidate will be responsible for developing and driving biomarker plans across clinical stage Infectious Disease programs.
This is an exciting opportunity for a motivated and experienced professional to work collaboratively across several clinical teams to ensure planning, execution, and data delivery of biomarker lab data for clinical trials conducted by BioSpace, Inc.
Key Responsibilities:- Evaluate technologies to identify, define, and implement the biomarker strategy to support the clinical development of our vaccines.
- Develop biomarker plans with input from the research and clinical leads.
- Manage biomarker assay labs to complete appropriate development, qualification, or validation studies in order to execute the clinical biomarker plan on time and with good quality.
- Ensure the timely and efficient delivery of all biomarker operational aspects across vaccine clinical trials: accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from planning, collection, analysis, data delivery, and final sample disposition with support from the Biosample Operations Manager.
- Develop and provide operational input and recommendations into all study-related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, and ensure collection, delivery, and analysis of biosamples in compliance with these documents as well as GCP/ICH.
- Serve as a single point of contact for biomarker operations across vaccine teams and with collaborators, assay labs, and CROs.
- Responsible for the identification and selection of biomarker vendors in collaboration with the Translational Science/Research leads.
- Manage the development and oversight of the biomarker analysis timelines, budget, risk, and quality plans.
- Attend operations team meetings and monitor training, CRO kick-off meetings, as applicable, to deliver trainings on biomarker activities.
- Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collection.
- MS (with at least 8 years pharmaceutical/biotechnology experience) or PhD (with at least 2-4 years of pharmaceutical or biotechnology experience) in a related science focus (i.e., immunology, molecular biology, biotechnology).
- Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure.
- Experience in Infectious disease programs (Ex: Human respiratory viruses / Human herpes viruses / HIV / Human Flaviviruses / Bacterial diseases) is highly desirable.
- Diagnostic assay development and testing experience is desirable.
- Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research, validation, and implementation.
- Experience in managing third-party assay laboratories, collaborations, and budget management.
- Strong communication and project management skills.
BioSpace, Inc. is a leading biotechnology company that is committed to innovation and excellence. We offer a comprehensive and innovative suite of benefits, including highly competitive and inclusive medical, dental, and vision coverage options, flexible spending accounts for medical expenses and dependent care expenses, lifestyle spending account funds to help you engage in personal enrichment and self-care activities, family care benefits, including subsidized back-up care options and on-demand tutoring, free premium access to fitness, nutrition, and mindfulness classes, exclusive preferred pricing on Peloton fitness equipment, adoption and family-planning benefits, dedicated care coordination support for our LGBTQ+ community, generous paid time off, including vacation, sick time, and holidays, volunteer time to participate within your community, discretionary year-end shutdown, paid sabbatical after 5 years; every 3 years thereafter, generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents, 401(k) match, and financial planning tools, Moderna-paid Life, LTD, and STD insurance coverages, as well as voluntary benefit options, complimentary concierge service including home services research, travel booking, and entertainment requests, free parking or subsidized commuter passes, and location-specific perks and extras.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. We are committed to offering reasonable accommodations to qualified job applicants with disabilities and are an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We are focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
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