Executive Director, Clinical Pharmacology (Remote)

Recursion; Opportunity (NE); Hybrid; USD 262,000 - 315,000; Full time

Job summary

Recursion is seeking an Executive Director of Clinical Pharmacology and Pharmacometrics to lead strategy and execution for a portfolio of rare disease and oncology programs. This remote opportunity in the United States places you at the core of regulatory interactions and cross-functional collaboration.

You will design clinical pharmacology studies from Phase 1 to 3, oversee PK/PD analyses, and represent PKs in submissions.

Qualifications

• 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 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 to support dose selection, exposure-response and exposure-safety analyses through various phases of drug development.
• Proficiency with WinNonlin, 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

Responsibilities

• Develop the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan.
• Lead clinical pharmacology strategy for programs in clinical development and act as the PK lead for regulatory interactions.
• Oversee modeling and simulation to expedite decision making and support dose selection.
• Design clinical studies and provide pharmacology input on study designs from Phase 1-3.
• Author clinical pharmacology sections for regulatory documents and assist in regulatory submissions.

Skills

Clinical pharmacology

Pharmacokinetics

PK-PD modeling

Regulatory interactions

Team leadership

Education

Ph.D. in Pharmaceutical Sciences / Pharmacokinetics or related

M.D. with Clinical Pharmacology expertise

PharmD with Clinical Pharmacology fellowship

Tools

WinNonlin

Monolix

NONMEM

R

Job description

Recursion is seeking an Executive Director of Clinical Pharmacology and Pharmacometrics to lead strategy and execution for a portfolio of rare disease and oncology programs. This remote opportunity in the United States places you at the core of regulatory interactions and cross-functional collaboration.

You will design clinical pharmacology studies from Phase 1 to 3, oversee PK/PD analyses, and represent PKs in submissions.