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Denali therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
The opportunity
Denali therapeutics is seeking to recruit a principal scientist in clinical pharmacology, who will be responsible for clinical pharmacology and modeling and simulation (m&s) strategies for denali`s biologics and small molecule programsThe candidate will be responsible for the design and implementation of strategies and clinical pharmacology studies and will write, edit, and finalize appropriate sections of regulatory filingsS/he will also play a key role in interactions with global health authorities and business development partnershipsWorking in close collaboration with denali colleagues in development sciences, early clinical development, translational sciences, and discovery, the candidate will also help execute the company`s drug development strategy and will participate and/or lead cross-functional project teamsThis position will report to the head of clinical pharmacology.
Responsibilities
Devise and lead the clinical pharmacology and m&s strategies and plans for biologics and small molecule drug candidates from pre-ind and first-in-human to all later phases of clinical investigation, including pivotal phase 2/3 studies and nda/maa/bla submissions
Develop clinical study designs and write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines
Write, edit, and finalize sections of ind/cta filings as well as nda/maa/bla submissions
Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities.
Conduct hands-on clinical pk/pd data analysis and advanced clinical modeling and simulation to support project needs
Requirements
Phd or pharmd in pharmaceutical sciences, pharmacokinetics, pharmacology or related scientific discipline, with 7+ years of relevant experience in clinical pharmacology and drug development in the pharmaceutical industry (or equivalent)
Experience in biologics drug development
Hands-on experience performing quantitative pk/pd data analyses (e.g., population pk, exposure-response analyses, pbpk)
Experience leading design and implementation of clinical pharmacology and m&s strategies for biologics and small molecules
Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex pk/pd data
Ability to work effectively and collaboratively on cross-functional projects teams
Excellent oral, presentation, and written communication skills
Expertise in neuroscience indications and/or oligonucleotide drug development preferred
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Posted 30+ days ago
