Description
You will join an innovative clinical development team dedicated to improving the lives of patients suffering from devastating diseases.
You will lead the innovative clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs.
Responsibilities:
- Develop clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan.
- Solve drug development questions/problems by performing and/or overseeing modeling and simulation with various tools to expedite decision making.
- Design clinical studies and provide 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.
- Interface with cross-functional teams, including clinical study teams, translational teams, preclinical teams, and due diligence teams.
The Team You’ll Join:
You will join the Pharmacometrics team within Recursion comprising clinical pharmacology, pharmacometrics, and translational modeling.
The Experience You’ll Need:
- 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.
- 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.
Working Location & Compensation:
This is a remote position based in the United States with required periodic travel.
Estimated annual base salary range:
- New York City, Boston, & San Francisco Bay Area(s): $287,980–$346,060
- Salt Lake City & all other U.S. locations: $261,800–$314,600
In addition to base salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.