Sr. Director, Clinical Pharmacology & DMPK

Role Summary

Manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM) and bioanalytical (BA) supports for Summit’s assets. Responsible for PK and PKPD data analysis to support projects.

Responsibilities

• Serve as Clinical Pharmacology and DMPK subject matter expert on cross-functional teams in both early and late-stage projects
• Define ADME strategy to achieve target product profile
• Design and outsource in vitro and in vivo ADME studies to characterize the compounds
• Oversee external bioanalysis including validation and sample analysis
• Design and perform complex PK analysis, model development, population PK and PK/PD analyses
• Interprets and presents Clinical Pharmacology and DMPK scientific data/results to the team
• Assists in clinical study protocol design, sample collection plan, data analysis/interpretation, and reporting
• Write, review and edit relevant sections of regulatory submissions – IND, DSUR, NDA, etc., and respond to queries from regulatory agencies
• All other duties as assigned

Qualifications

• Required: Ph.D., Pharm.D., or equivalent in Pharmacokinetics, Pharmaceutical sciences, Biostatistics, or related disciplines with a minimum of 7+ years of clinical pharmacology industry experience, or MS with 10+ years of relevant experience
• Required: Hands-on experience with standard PK software (e.g., Phoenix WinNonlin)
• Required: Demonstrated computational skills related to pharmaceutical or biomedical research with hands-on programming skills in SAS, R, MATLAB; experience with population PK analysis and PKPD modeling tools (e.g., NONMEM, and other modeling platforms) is required
• Required: Detail-oriented, highly organized, and able to manage multiple tasks
• Preferred: Strong project management skills, ability to prioritize and manage multiple projects simultaneously
• Preferred: Ability to function in a fast-paced environment with good communication and problem-solving skills

Education

• Ph.D., Pharm.D., or equivalent training in Pharmacokinetics, Pharmaceutical sciences, Biostatistics, or related disciplines with a minimum of 7+ years of clinical pharmacology industry experience or MS with 10+ years of relevant experience