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Position:
Scientist / Sr. Scientist, DMPK (Protein Therapeutics)

Employer:
Denali Therapeutics

Description:

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 hire a Scientist/Sr. Scientist specializing in pharmacokinetics (PK) and biodistribution of protein therapeutics.  The incumbent will work closely with scientists in Discovery Biology and Translational Biomarkers to design and conduct PK/PD studies, analyze data, interpret results, and provide strategic guidance to project teams.  Additionally, collaborations with colleagues in Research, Development Sciences, and Clinical Development will be required to advance protein therapeutics into early clinical development.  The successful candidate will help conduct and manage both internal and external studies, contracting with CRO partners as needed.  The successful candidate will write, edit, and finalize appropriate sections of regulatory filings, and play a role in interactions with global health authorities. In addition, the candidate will provide modeling and simulation support to project teams. This position will report to the Head of Quantitative Pharmacology.

 

Responsibilities

  • Support internal large molecule Discovery Project Teams during lead optimization and candidate selection; contribute PK and biodistribution expertise to enable team success.
  • Help identify key aspects of target biology impacting PK properties and duration of PD response; contribute to efforts to optimize candidate characteristics accordingly.
  • Partner with in vivo translational and bioanalytical scientists to design and conduct PK and biodistribution studies; perform PK/PD analyses to establish quantitative understanding of exposure-response relationships.
  • Analyze, interpret, summarize, and present PK and disposition data to internal project teams, senior management, and to global health authorities.
  • Provide support for externally sourced non-GLP nonclinical PK and biodistribution studies.
  • Advance clinical candidates in the company portfolio; write, edit, and finalize nonclinical PK sections of regulatory (IND/CTA) filings and contribute to clinical protocol development.
  • Develop and apply PK/PD models to inform project team goals such as target and compound evaluation, biomarker investigation, preclinical and clinical study designs.
  • Build effective collaborations with peers across the organization.


Qualifications/Experience:

Requirements

  • PhD in Pharmacokinetics, Pharmacometrics, Biochemistry, or related scientific discipline, with industry/post-doctoral experience 1-4 or 4-8 years
  • Established expertise in large molecule disposition and PK, with working knowledge of biological factors and molecule attributes impacting tissue biodistribution.
  • Experience investigating PK/PD relationships for large molecule therapeutics, including analysis using appropriate software applications.
  • Understanding of immunoassay/ligand binding assay techniques employed for quantification of protein therapeutics in biological matrices.
  • 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 projects teams.
  • Excellent oral, presentation, and written communication skills.
  • Experience with relevant software or programming languages (e.g., Simbiology, MATLAB, R, or C) for modeling and simulation is preferred but not essential.


Location: South San Francisco

Contact: cobin@dnli.com

Post Date: 3/8/2021 2:36:41 PM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 4/13/2021; Admin Logon
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