Director, DMPK

Denali Therapeutics•South San Francisco, CA

7d•$212,000 - $276,000

About The Position

This role leads a dedicated DMPK team within the Nonclinical Safety Assessment and DMPK group within the Development Sciences organization, providing scientific and strategic input to advance a portfolio of blood-brain-barrier penetrant biotherapeutics from Discovery through CTA/IND-enabling studies, as well as ultimately supporting registration. Serving as both a hands-on subject-matter expert and a people leader, this individual collaborates closely with Discovery Sciences, Translational Medicine, and Regulatory teams to shape PK, drug disposition, and translational pharmacology strategy across project teams. The incumbent builds scientific talent within the Nonclinical Safety Assessment and DMPK group and represents DMPK on the Development Sciences Leadership Team.

Requirements

Typically requires a PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology/Toxicology, Engineering, or a related field.
Typically requires 10+ years of relevant experience, including 8+ years of people management, mentorship, and coaching experience.
Established expertise in biotherapeutic drug disposition and pharmacokinetics, with a track record identifying clinical candidates and advancing molecules through CTA/IND milestones to first-in-human trials.
Proven ability to evaluate drug properties impacting PK, investigate PK/PD relationships, and apply relevant bioanalytical methods (ligand binding assays, mass spectrometry, or other methodologies).
Demonstrated success leading and/or serving on cross-functional Project Teams, contributing to data-driven decision-making and drug development strategy.

Responsibilities

Lead and manage a group within the Nonclinical Safety Assessment and DMPK organization, providing strategic, project-focused vision and oversight to advance drug candidates from Discovery through CTA/IND-enabling studies into early clinical development ultimately supporting BLA submission.
Deliver on Project Team objectives by contributing scientific expertise in pharmacokinetics, drug disposition, biodistribution, and translational pharmacology/pharmacodynamics.
Participate on Project Teams as a subject-matter expert, contributing to optimization and selection of lead clinical candidates, and support group members serving in this capacity.
Design nonclinical PK/PD studies to answer translational questions supporting project deliverables and first-in-human dose predictions; oversee TK analysis for non-GLP and GLP toxicology studies.
Lead Project Teams and Pharmacology Technical Teams through the CTA/IND-enabling stage of drug development.
Serve on the Development Sciences Leadership Team, contributing to Functional and Organizational strategy including goal setting and staff development.
Establish and maintain productive relationships with Discovery Sciences, Bioanalytical Sciences, Nonclinical Safety Assessment, Clinical Pharmacology, Quantitative Pharmacology, Translational Medicine, and Regulatory to advance projects to key decisions and development milestones.
Analyze, interpret, and communicate data to project teams, senior management, global health authorities, and strategic partners.
Author and review nonclinical and clinical sections of regulatory filings.
Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance, and provide ongoing feedback on growth and development.