Director, Clinical Pharmacology

Overview

Director, Clinical Pharmacology role d the clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs.

• Develop the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan. You’ll be the Clinical Pharmacology lead for various programs in clinical development, the representative for regulatory interactions, and propose innovative strategies to get therapies to patients faster.
• Design clinical studies. You’ll provide (clinical) pharmacology input on all clinical study designs, from Phase 1-3 and dedicated Phase 1 clinical pharmacology studies.
• Author review relevant clinical pharmacology sections for regulatory documents, including Investigator's Brochures (IB), INDs, NDAs, and other regulatory submissions. Act as the clinical pharmacology expert during interactions with health authorities.
• Interface with cross-functional teams. You’ll work closely with clinical study teams, translational teams (DMPK, Translational Modeling and Toxicology), preclinical teams and due diligence teams to ensure clinical pharmacology-related considerations are addressed.
• Solve drug development questions/problems by overseeing and/or performing modeling and simulation with various tools to expedite decision making.

You will join the Development Sciences team within Recursion comprising clinical pharmacology, pharmacometrics, translational modeling and clinical biomarkers. The Development Sciences group sits within Recursion’s Clinical Development organization. Team members work in an end-to-end environment at Recursion and collaborate with clinical development and discovery functions including clinical science, clinical operations, regulatory affairs, biostatistics, DMPK, Biology, Chemistry and Translational Biomarkers.

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline, M.D with a Clinical Pharmacology expertise, or a Pharm
  
  D. with a Clinical Pharmacology fellowship, with 5-9+ 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 to support dose selection, exposure-response and exposure-safety analyses through various phases of drug development.
• Proficiency with Win Nonlin, Monolix, NONMEM, R or other modeling software.
• Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external 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 individual who is proactive, resourceful, and efficient with the flexibility and creativity to excel in and contribute to a rapidly growing drug discovery and development company

Experience in oncology is preferred, but not an absolute requirement.

This position can be based in either Salt Lake City or New York City. The role is hybrid, with an expectation to spend 50% of time in the office. The estimated current annual base salary range is $212,900 to $281,600
. You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.

• We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
• We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
• We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
• We move with urgency because patients are waiting.…