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Salary: USD 261,800 - 346,060 / annual
Recursion Pharmaceuticals, a clinical-stage TechBio company, is seeking an Executive Director of Clinical Pharmacology and Pharmacometrics to lead the clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs.
In this role, you will develop clinical pharmacology and pharmacometric strategies to accelerate product development, serving as the clinical pharmacology lead for various programs in clinical development and as the regulatory representative. You will solve drug development questions through modeling and simulation using various tools to expedite decision-making. You will design clinical studies, providing pharmacology input on Phase 1-3 and dedicated Phase 1 clinical pharmacology studies. You will author clinical pharmacology sections for regulatory documents including Investigator's Brochures (IB), INDs, NDAs, and other regulatory submissions, and act as the clinical pharmacology expert during health authority interactions.
You will interface with cross-functional teams including clinical study teams, translational teams (DMPK, Translational Modeling and Toxicology), preclinical teams, and due diligence teams. The Pharmacometrics team sits within Recursion's Clinical Development organization and collaborates closely with clinical development functions (clinical science, clinical operations, regulatory affairs, biostatistics) as well as discovery functions (DMPK, Biology, Chemistry, and Translational Biomarkers).
Recursion is advancing a differentiated pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas. The company's Recursion OS is an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development. The role is remote based in the United States with required periodic travel.
REQUIREMENTS:
- Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline; M.D. with Clinical Pharmacology expertise; or Pharm.D. with Clinical Pharmacology fellowship
- 10+ years of experience in biotech/pharmaceutical drug development
- Demonstrated success leading all clinical pharmacology related aspects of drug development
- Ability to work closely with internal and external stakeholders to manage PK, PK-PD, and PK-safety analyses, including non-compartmental analysis, population PK modeling, and PK-PD modeling and simulations
- Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software
- Effective skills in driving collaboration, achieving results, influencing, and resolving conflicts across stakeholders
- Demonstrated experience responding to regulatory agency questions, preparing clinical pharmacology aspects of regulatory submissions, and attending regulatory meetings
- Highly motivated, decisive, and results-oriented with proactive, resourceful, and efficient approach
- Experience in oncology preferred but not required
