Director, Drug Metabolism

What is this role really like?

Mirati Therapeutics is seeking an experienced and highly motivated head of DMPK to establish and lead this function in our fast paced and passionate drug discovery group. The successful candidate will build in-house DMPK and proteomics capabilities and will take the lead role in setting DMPK strategies for small molecule discovery programs, planning and executing drug metabolism, pharmacokinetic and toxicokinetic studies using internal and external resources, and provide human physiology-based PK (PBPK) and efficacious dose predictions for lead molecules.  You will be an essential member of discovery project teams, proactively identifying DMPK risks and suggesting solutions for the team. Working in coordination with the clinical pharmacology group, the head of the research PK group will support clinical programs as requested and integrate clinical PK results into next-generation discovery project strategies.  You form strong working interactions with project scientists across discovery including pharmacologists, biochemists, structural biologists, and medicinal chemists. In addition, you are comfortable communicating and presenting your work to members of multi-disciplinary project teams and can teach your coworkers the underlying details of DMPK to help guide them in their decision-making process.

Day-to-Day Duties:

• Responsible for all aspects of DMPK and proteomics for drug discovery projects from preclinical research into IND-enabling studies, assisting early clinical development as requested
• Design and manage internal and external DMPK studies in support of projects
• Identify key DMPK issues and design in vitro and in vivo ADME experiments to address these
• Design in vivo PK and toxicity studies, interpret PK, TK and ADME data and communicate results to project teams
• Perform modelling and simulations of human PK and efficacious dose to enable lead selection, evaluation of DDI risk and selection first in human dose
• Internalize and perform hands-on targeted and un-targeted proteomics experiments
• Acquire and interpret high resolution mass spectroscopy (HRMS) data to support drug metabolism studies
• Provide IND packages and interact with regulatory agencies regarding preclinical data
• Support physical chemical profiling and dose form selection for PK and toxicity studies
• Supervise and provide mentorship to DMPK scientists
• Effectively collaborate and interface other functional areas such as medicinal chemistry, pharmacology, toxicology and clinical pharmacology
• Provide excellent communication, interpersonal and leadership skills, and detail-oriented support to a fast-paced team environment

What would a successful candidate look like?

• BS/MS/PhD in pharmacology/pharmaceutical sciences/analytical chemistry with 24/21/8 or more years of drug development experience in pharmaceutical/biotech companies.
• Experience in designing and conducting non-GLP and GLP studies for lead candidate selection and IND filing
• Expertise in drug metabolism studies using HRMS is required.
• Strong analytical chemistry skills and proficiency in MS-based proteomics data acquisition and interpretation is desired.
• Hands-on experience with DMPK/ADME experiments and willingness to execute those experiments when necessary
• Experience in GastroPlus PBPK modelling and Phoenix WinNonlin analysis of PK/PD data and the prediction of human PK and efficacious dose for lead compounds is highly desired
• Ability to manage several programs simultaneous and quickly adapt to change
• Excellent time management, communication and collaborative skills

Mirati is an Equal Opportunity Employer (EOE) – we celebrate diverse experiences and welcome applicants that meet the minimum requirements. All applicants must be legally authorized to work in the US without sponsorship.

This role is NOT open to agencies- please no emails or phone calls.