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Director of Biomarker Implementation and Clinical Data Management
3 months ago
About the job
💻 Director of Biomarker Implementation/ Clinical Data management- Oncology
🌎Hybrid, San Diego
💵$250k - $350k
We are working with an Artificial Intelligence-driven Drug Discovery (AIDD) team in San Diego on a Director of Biomarker Implementation/Clinical Data management. This role is crucial in advancing our oncology programs, with a focus on the operational implementation of biomarker assays and the management of clinical data. This position offers the opportunity to build and lead a world-class biomarker team in a fast-growing company, ensuring the seamless integration of biomarker assays into clinical trials and robust clinical data management.
Responsibilities
- Scientific and Operational Leadership: Lead biomarker data collection in clinical trials and non-interventional studies, ensuring robust and reliable data.
- Translational Collaboration: Work with preclinical, translational, and clinical scientists to translate biomarker discoveries into clinical assays, including genetic/NGS tests, mRNA expression assays, protein biomarkers, metabolite assays, and imaging biomarkers.
- Oncology Biomarker Discovery: Develop omics-based approaches to discover and validate biomarkers specifically for oncology, facilitating the deployment of drug candidates in cancer treatments.
- Clinical Trial Integration: Incorporate biomarker testing into clinical trial plans to support patient selection and track pharmacodynamic and disease modification biomarkers.
- Outsourced Assay Management: Oversee all technical aspects of outsourced biomarker assays, including vendor identification, assay qualification/validation, and ensuring timely data delivery.
- Regulatory Compliance: Ensure biomarker assays comply with all relevant regulatory requirements.
- Sample Management: Establish and manage a biomarker sample storage and inventory plan, including identifying third-party vendors, ensuring regulatory compliance, and developing a sample database and tracking system in collaboration with biology, clinical science, and bioinformatics teams.
- Data Management: Oversee biomarker data transfer among clinical sites, assay vendors, and internal teams, ensuring relevant metadata is associated with samples. Collaborate with bioinformatics and clinical biostatistics teams to develop data transfer protocols and ensure data protection.
Skills and Qualifications
- Educational Background: PhD in Cell, or Molecular Biology or related field with a minimum of 12 years of post-PhD experience, specifically in oncology.
- Practical Experience: Proven track record of hands-on and outsourced biomarker assay implementation in oncology.
- Regulatory Knowledge: Comprehensive understanding of regulatory requirements for biomarker testing in clinical trials.
- Organizational Skills: Exceptional organizational and project management skills.
- Interpersonal Skills: Strong interpersonal, influencing, and collaboration skills to work effectively in a team-oriented, fast-paced environment.
Why Join this team?
- Innovative Environment: Be part of a cutting-edge AIDD team pushing the boundaries of translational oncology.
- Impactful Work: Drive the development of new cancer treatments by bridging the gap between preclinical discoveries and clinical applications.
- Collaborative Culture: Work with a dynamic team of scientists and professionals dedicated to making a difference in cancer therapy.
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