Director, DMPK

Reporting to our Head of DMPK, the Director of DMPK is a strategic leader and critical member of Nimbus’ growing Drug Discovery and Development organizations. The individual in this role will lead crucial elements of DMPK research on projects at various stages in the Drug Development Pipeline.

In this role, you will:

• Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates that support both drug discovery and preclinical and clinical development
• Responsible for the analysis, interpretation, integration and reporting of preclinical DMPK data generated both internally and with external collaborators
• Represent DMPK as the subject matter expert to project teams
• Establish effective relationships with CROs, consultants, and internal team members to develop and qualify methods of assessing quantities of oligonucleotide and metabolites in cells and tissues
• Design, contract and manage CRO in the conduct of in vitro / in vivo ADME studies. Review study protocols and reports, interpret and communicate results
• Prepare strategic and scientifically sophisticated ADME strategies that meet regulatory requirements and program goals
• Author, review and approve scientific reports that support regulatory documents including INDs, CTAs, and NDA filings. Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments
• Operate as a willing collaborator in a matrix team environment

These qualifications will help this role be successful:

• Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutical Science or other relevant field with 5+ years of experience within in the biopharmaceutical industry
• Strong understanding of DMPK, PK/PD modeling and human dose predictions to enable the design of preclinical and clinical studies, is required
• Hands-on experience with relevant modeling software and programming languages including MATLAB, R, Python, WinNonLin/Phoenix, etc. is required
• Prior experience with regulatory submission (e.g., IND, BLA and/or NDA) is a plus
• Excellent verbal and written communication and organizational skills required with experience working on cross functional teams
• Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment

A S