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

The Company is seeking to recruit a Director, Bioanalytical Sciences responsible for development of scientifically rigorous bioanalytical strategies and leadership of a bioanalytical team supporting Discovery and Development of novel blood brain barrier penetrant biotherapeutics and small molecules, as well as key clinical biomarkers.  Working collaboratively with Discovery, Development Sciences, Translational Sciences, and Clinical Development colleagues, the candidate will design and execute bioanalytical strategies for projects across the portfolio and successfully deliver bioanalytical results for PK/PD, GLP toxicology, and clinical studies, while adhering to established regulatory guidelines, when appropriate.  In addition to leadership of a functional team, the incumbent will also serve on cross-functional Project Teams, prepare relevant sections of regulatory filings, and play a key role in interactions with global health authorities.

Responsibilities

  • Establish innovative Bioanalytical strategies for novel biotherapeutics (including engineered immunoglobulins, fusion proteins, nucleic acids, and AAVs) including measurement of both drug concentrations and ADA responses.
  • Help guide strategic thinking related to small molecule bioanalysis and clinical biomarkers.
  • Lead an experienced Bioanalytical Team/Functional Group; enable Bioanalytical efforts for both Discovery and Development stage programs through strategic leadership and direct participation on Project Teams.
  • Write, review, and finalize Bioanalytical study reports that adhere to global regulatory guidelines and are suitable to support IND/CTA/BLA/NDA filings.
  • Analyze, interpret, summarize and present data to internal Project Teams, senior management, and global health authorities; prepare regulatory summary documents, briefing packages, and immunogenicity risk assessments.

Requirements

  • PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related scientific discipline with 15+ years of biotechnology or biopharmaceutical drug development experience; or BS/MS with 20+ years of experience.
  • Demonstrated expertise in bioanalysis of novel biotherapeutics (including engineered antibodies, fusion proteins, nucleic acids, AAVs, etc.), small molecules, and biomarkers.
  • Deep knowledge and understanding of bioanalytical tools and instrumentation.
  • Thorough mastery of regulatory guidance (FDA and ICH) covering bioanalysis of therapeutics and biomarkers; successful preparation and filing of regulatory summary documents and conduct of written or in person regulatory interactions.
  • Deep expertise in design and conduct of bioanalytical method development, assay qualification, and assay validation supporting regulated and clinical studies.
  • Excellent critical thinking and scientific skills, and ability to analyze, interpret, and clearly communicate complex bioanalytical data.
  • Experience in design of workflows balancing internal conduct and outsourcing of key nonclinical and clinical studies.
  • Ability to work effectively and collaboratively on cross-functional Projects Teams.
  • Excellent oral presentation and written communication skills.

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