Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
The Company is seeking to hire a Principal Scientist, DMPK with expertise in small molecule drug discovery and early development. The successful candidate will be expected to represent the DMPK function on projects, guiding and implementing strategies and enabling timely data-driven decision-making throughout the life cycle of small molecule therapeutics. Key deliverables are human PK and efficacious dose predictions and clinical risk assessment based on translating in vitro and nonclinical data. The incumbent will be a key team member for identifying and advancing drug candidate molecules in collaboration with colleagues in Medicinal Chemistry, Safety Assessment, Biology, Development Sciences, and Clinical Development.
- Be a key contributor to DMPK strategy from drug discovery to drug development and filing by acting on interdisciplinary project teams to identify and address ADME-centered matters for small molecule therapies
- Guide project teams to characterize, select, and advance small molecules with ADME properties that are fit to the therapeutic profile; accomplishing this through designing and integrating data from in vitro and preclinical pharmacokinetic/toxicokinetic studies, and translating to predictions of human PK, PD, and safety
- Effectively communicate DMPK data and its interpretation for decision-making to project teams
- Manage and oversee external vendors for completing in vitro and in vivo studies
- Act as a key member of Pharmacology teams to develop and execute strategies for nonclinical and clinical ADME characterization of candidate molecules to support their advancement in clinic studies
- Serve as a subject matter expert to write Nonclinical Pharmacology sections of regulatory (IND/CTA) filings, IB updates, and responses to regulatory queries
- MS or PhD in Drug Metabolism, Pharmacokinetics, Chemistry, or related scientific discipline with a minimum 8-12 years of biotech/pharmaceutical drug discovery and development experience or BSc with 15+ years of experience
- Excellent critical thinking and scientific skills with proven scientific expertise in small molecule metabolism and pharmacokinetics
- Demonstrated success working effectively and collaboratively on cross-functional projects teams
- Excellent oral presentation and written communication skills
- Working remotely to the SF Bay Area can be considered for the correct candidate