Director – Quantitative Pharmacology
Posted on 3/26/2024
INACTIVE
Denali Therapeutics

201-500 employees

Develops therapies for neurodegenerative diseases
Company Overview
Denali Therapeutics stands out as a leader in the field of neurodegenerative diseases, leveraging recent scientific insights into genetic causes and biological processes to develop effective treatments for conditions like Alzheimer's, Parkinson's, and ALS. The company's culture is characterized by a commitment to rigorous science, translational medicine, and collaboration, fostering an environment where diverse backgrounds and experiences unite behind the shared goal of defeating degeneration. Denali's competitive advantage lies in its deep expertise in neurodegenerative disease biology and the blood-brain barrier, which informs a robust portfolio of programs at various stages of clinical and preclinical development, all aimed at improving patient lives by addressing disease causes or risk factors.
Biotechnology

Company Stage

N/A

Total Funding

$1.1B

Founded

2015

Headquarters

South San Francisco, California

Growth & Insights
Headcount

6 month growth

-8%

1 year growth

-5%

2 year growth

7%
Locations
San Bruno, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
R
CategoriesNew
Computational Biology
Lab & Research
Biology & Biotech
Requirements
  • PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, Engineering, or related scientific discipline, with 10+ years of relevant biotech/biopharmaceutical experience.
  • Established expertise constructing mathematical models to describe drug disposition and pharmacodynamic response to investigate preclinical and clinical PK/PD relationships using standard pharmacometrics software (e.g., NONMEM, R).
  • Demonstrated success building and leading Modeling & Simulation/Pharmacometrics Groups to support advancement of drug candidates through development milestones.
  • Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex results.
  • Ability to work effectively and collaboratively on cross-functional project teams.
  • Experience with regulatory interactions and submissions (NDA, ANDA, BLA).
Responsibilities
  • Lead and develop the Quantitative Pharmacology team to provide strategic direction and technical oversight of M&S activities and pharmacometrics analyses spanning Discovery, IND-enabling, and Clinical Development phases.
  • Construct translational PK/PD models and establish exposure-response relationships to inform target validation efforts and dose selection decisions; mentor team members performing these activities.
  • Select and manage pharmacometrics vendors conducting population PK/PD and exposure-response analyses in support of regulatory submissions for late-clinical stage programs.
  • Lead Pharmacology Technical Teams in the IND-enabling and clinical development stage.
  • Serve on the Development Sciences Leadership Team; set Function and Organizational goals.
  • Establish and maintain productive relationships with key partners within the organization, including Discovery Sciences, Translational PK, Clinical Pharmacology, Translational Medicine, Clinical Development, and Regulatory to advance projects to key decisions and achieve development milestones.
  • Recruit and develop talent in the QP group; manage internal and external resources effectively to achieve organizational goals.
  • Analyze, interpret, summarize and communicate data to internal project teams, senior management, global health authorities, and strategic partners.
  • Contribute to authoring and reviewing nonclinical and clinical sections of regulatory filings and interact with global health authorities.