Senior Manager, Clinical Pharmacology & Dmpk

Overview of Role:

The Senior Manager, Clinical Pharmacology & DMPK will manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM) and bioanalytical (BA) supports and operation for Summit's assets. This role is responsible for PK and ADA samples management, vendor management, and perform data analysis to support projects.

Role and Responsibilities:

• Serve as Clinical Pharmacology and DMPK subject matter expert on cross-functional teams in both early- and late-stage projects
• Design and outsource in vitro and in vivo ADME studies to characterize the compounds
• Manage external vendors for bioanalysis including validation and sample analysis
• Oversee the collection, processing, storage, tracking, distribution and reconciliation of PK/ADA samples
• Ensure data integrity and compliance with Good Clinical Practice (GCP) regulations throughout the drug development process
• Collaborate with cross functional teams and central laboratories to manage sample logistics and chain-of-custody procedures
• Perform NCA data analysis/interpretation, and reporting
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Ph.D., Pharm.D., or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with 1+ years of clinical pharmacology industry experience or M.S. with 5+ years of relevant experience
• Experience in clinical trial design and execution, preferably in various phase clinical studies
• Understanding of clinical pharmacology concepts and conducting clinical pharmacology studies and knowledge of regulatory requirements related to clinical trials (GCP, ICH guidelines), and drug development
• Hands-on experience with standard PK Software (e.g., Phoenix WinNonlin).
• Strong project management skills and ability to prioritize and manage multiple projects simultaneously
• Excellent communication, organizational and problem-solving skills