Associate Director/Director, Clinical Pharmacology

The role

The Associate Director/Director in Clinical Pharmacology will support a clinical portfolio of gene/base editing therapeutics. This person will operationalize model-based drug development by integrating modeling results into clinical study design, regulatory documents, and internal decision-making.

What you will do

• Provide critical input in build-out of the Clinical Pharmacology function.
• Operationalize model-based drug development.
• Serve as key functional expert to lead, direct, and coordinate modeling projects.
• Conduct PK and PK/PD analyses and modeling using nonclinical and clinical data.
• Contribute to protocol and study report writings.
• Present key pharmacometrics analyses results to internal and external stakeholders.
• Facilitate model-based drug development to support clinical programs.
• Develop and write pharmacometrics analysis plans and author reports.
• Define and drive pharmacometrics contributions to regulatory/submission strategy.
• Provide strategic expertise and leadership for development programs.

Required qualifications

• MD, PhD, or PharmD in Pharmacokinetics, Pharmacology, Pharmacology, Pharmaceutics or other relevant field.
• Typically, 10+ years experience with 3 to 10 years of experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience.
• Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development.
• Expertise in quantitative systems pharmacology (QSP).
• Expertise in pharmacokinetics, PKPD principles, ADME concepts, and clinical pharmacology.
• Expertise in Phoenix WinNonLin, NONMEM and R, or other pharmacokinetic, modeling and data visualization software.
• Strong communication skills (verbal and written) and presentation skills.
• Excellent interpersonal skills and the ability to function in a highly matrixed team environment.
• Experience and willingness to mentor and develop others.
• Expertise in translational modeling in in-vivo and ex-vivo gene editing therapeutics.

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.