Staff/ Senior Staff Scientist, DMPK

The role

You will define and execute DMPK, PK, and PK/PD strategy across a drug discovery and development portfolio. You will partner with discovery project teams to characterize compounds from hit identification through candidate selection and clinical development.

What you will do

• Define and execute ADME/PK and PK/PD strategy for discovery and development programs
• Design, execute, and interpret studies assessing ADME and drug-drug interaction potential
• Apply mechanistic approaches to translate dosing regimens from preclinical to clinical
• Analyze and present PK/PD data to project teams and senior management
• Develop in vitro/in vivo assays to characterize ADME/PK and DDI profiles
• Manage CRO relationships and outsourced DMPK study execution
• Author and review DMPK sections of regulatory submissions
• Serve as the DMPK representative or Project Team Leader on cross-functional discovery teams
• Mentor junior scientists

Required qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology, Chemistry, Biochemistry, or a related field
• 5+ years of DMPK drug discovery experience post-Ph.D.
• Substantial experience in a biotechnology or pharmaceutical setting
• Strong understanding of nonclinical in vivo pharmacokinetics, absorption/clearance mechanisms, drug metabolism, transporters, drug-drug interactions, and in vitro methodologies
• Demonstrated experience leading DMPK efforts across programs spanning multiple target classes and therapeutic areas
• At least one program that advanced to a clinical drug candidate
• Experience serving as a lead DMPK representative on cross-functional project teams
• Experience managing externally outsourced DMPK studies
• Strong scientific track record and reputation as an effective technical leader
• Excellent communication skills across a range of audiences
• Hands-on experience developing in vitro/in vivo assays for ADME/PK and DDI characterization
• Experience contributing to regulatory submissions

Benefits

• stock options
• annual target bonus

About the company

Septerna is a biotechnology company based in South San Francisco, CA. The company uses a Native Complex Platform™ to develop GPCR-focused medicines.