Director, Clinical Pharmacology

About the role

The Director, Clinical Pharmacology will lead the clinical pharmacology and pharmacometric strategy and execution for a portfolio of rare disease and oncology clinical programs. Reporting to the Head of Development Sciences, you will be responsible for developing clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan. You will also serve as the Clinical Pharmacology lead for various programs in clinical development, representing the clinical pharmacology perspective in regulatory interactions, and proposing innovative strategies to bring therapies to patients faster.

Responsibilities

• Develop clinical pharmacology and pharmacometric strategies to support the overall product development plan.
• Lead clinical pharmacology and pharmacometric activities for various programs in clinical development.
• 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.
• Interface with cross-functional teams, including clinical study teams, translational teams (DMPK, Translational Modeling and Toxicology), and preclinical 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.

Requirements

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

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 5-9+ years of experience in biotech/pharmaceutical drug development.
• Proven track record of leading clinical pharmacology and pharmacometric activities for various programs in clinical development.
• Strong proficiency with modeling and simulation tools such as WinNonlin, Monolix, NONMEM, R, or similar software.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with internal and external stakeholders.
• Experience in oncology is preferred, but not a requirement.

Skills

• Expertise in clinical pharmacology and pharmacometrics.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Strong regulatory knowledge and experience in preparing clinical pharmacology sections for regulatory submissions.

Benefits

At Recursion, we offer a comprehensive benefits package, including:

• Annual bonus
• Equity compensation
• Comprehensive benefits package

Pay

The estimated annual base salary range for this role is:

• New York City, Boston, & San Francisco Bay Area(s): $234,190–$287,980
• Salt Lake City & all other U.S. locations: $212,900–$261,800

Schedule

We ask that remote employees commit to regular on-site visits for routine work and departmental events.