Director of Clinical Biomarkers
Company | Recursion Pharmaceuticals |
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Location | Salt Lake City, UT, USA, London, UK, Oxford, UK, New York, NY, USA |
Salary | $217200 – $295900 |
Type | Full-Time |
Degrees | PhD, JD |
Experience Level | Senior, Expert or higher |
Requirements
- PhD, MD or equivalent in a relevant scientific discipline with 8+ years of biopharmaceutical industry experience with a solid understanding of drug discovery and early development
- Extensive experience in clinical biomarkers/diagnostics and/or translational research; Strong understanding of clinical studies and working within cross-functional study/program teams contributing to biomarker relevant documents, plans, operations and workstreams
- Knowledge of regulatory requirements, best practices in applying translational science and biomarker assay development and validation to support global clinical trials
- Strong understanding of various technology platforms and datasets, including omics, for discovery, validation and implementation of biomarkers; Familiarity with effectively engaging vendors and CROs providing services for biomarker assays
- Expertise in one or more of the following therapeutic areas: oncology, rare disease, immunology/inflammation
- Ability to think critically, strategically, practically to enable decision making and influence R&D teams and stakeholders; Track record in problem solving, data analysis/interpretation and team science innovation
Responsibilities
- Lead the overall biomarker strategy and execution for assigned program(s) in the Recursion portfolio by serving as the clinical biomarker lead on program/study teams
- Develop plans collaboratively to deliver fit-for-purpose pharmacodynamic, predictive, prognostic and/or other biomarker assays to support decision making in early development. Work with discovery teams to support preclinical to clinical transitions of programs and align overall translational and biomarker strategies
- Partner with various research and clinical teams, including Clinical Operations, Stats, Data Management, Project Leadership, etc., to contribute to biomarker-related aspects of trial design and conduct, study documents (e.g. protocols, study reference manuals, study reports, INDs etc.), trial readouts/endpoints and regulatory interactions
- Actively manage CROs, vendors, suppliers and other groups for assay development and qualification/validation. Oversee the operational aspects of biomarker implementation, including sample logistics, data management, and coordination with internal teams and CROs
- Stay current with emerging science and innovate with novel technologies and approaches to generate/analyze/apply data and derive insights on mechanisms, indications, combinations and patient selection/stratification
- Present biomarker findings at key internal and external meetings
Preferred Qualifications
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No preferred qualifications provided.