Director of Clinical Biomarkers

Company: Recursion

Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data. Recursion has a strong and diverse pipeline that spans first-in-class and best-in-class assets across oncology and rare disease.

As Director of Biomarkers, you will serve as the Biomarker lead on clinical program teams and will be responsible for delivering on fit-for-purpose biomarker strategies that include predictive and pharmacodynamic biomarker assays. You will leverage your deep understanding of the scientific, regulatory and operational aspects of biomarkers, to implement appropriate measurements that enable clinical decision making, and the development of safe and effective medicines to address unmet medical need.

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.

You will join the Development Sciences team, will report to the Head of Clinical Biomarkers, and will be part of the Clinical Development organization at Recursion. The Development Sciences team is a group of project-facing Translational scientists that supports the transition of projects from discovery into clinical development and beyond. Core functions within this team include translational PK/PD modeling, clinical pharmacology, clinical bioanalysis and biomarkers. This is a collaborative group of scientists who:

• Work closely with discovery to ensure the progression of the right molecule at the right dose for the right patient.
• Support IND filings.
• Ensure the continued implementation of the appropriate translational strategies for projects in clinical development.

In this role you will have the opportunity to work seamlessly with the drug discovery and clinical development organizations at Recursion to ensure that we apply the best science in service of the portfolio.

The Experience You’ll Need:

• 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.