Principal Scientist, Large Molecule Pharmacokinetics

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, Large molecule Pharmacokinetics expert to design and conduct PK/PD and biodistribution studies to support Discovery and Development of novel blood-brain-barrier penetrant transport vehicle (TV) biotherapeutics, including oligonucleotide transport vehicle conjugates. The Principal Scientist will collaborate with scientists in Discovery Biology, Preclinical Translational Sciences, and Translational Medicine, serving on project teams and providing strategic input to advance promising candidates to clinical trials. The successful candidate will write, review, and finalize appropriate sections of regulatory filings, and play a role in interactions with global health authorities.

Responsibilities

• Serve on teams as the PK expert contributing to the optimization and selection of lead candidates.

• Support efforts to identify key aspects of target biology impacting PK properties and duration of PD response.

• Perform PK/PD analyses to establish quantitative understanding of exposure-response.

• Work closely with our bioanalytical scientists, biologics discovery, toxicology, clinical. pharmacology, and regulatory teams to optimize leads, to select candidates for clinical evaluation, and contribute to regulatory filings.

• Analyze, interpret, summarize, and present PK and disposition data to internal project teams, senior management, and to global health authorities.

• Prepare study protocols and coordinate execution of nonclinical PK or PK/PD studies to answer translational questions in support of project deliverables and first-in-human dose predictions.

• Contribute to the design and TK analysis for non-GLP and GLP toxicology studies.

• Work closely with project teams, line management and CROs to assure high quality and timely delivery of written reports for regulatory submissions.

• Write, review, and finalize nonclinical PK sections of regulatory (IND/CTA) filings and contribute to clinical protocol development.

Requirements

• A highly motivated individual with a PhD in pharmacokinetics, pharmacology/toxicology, immunology, biochemistry, engineering, or related field with industry/post-doctoral experience of 7+ years, or BS/MS with 12+ years.

• Established expertise in large molecule pharmacokinetics, with experience in the biological factors and molecular physicochemical attributes that may impact PK and disposition.

• Proven track record investigating PK/PD relationships for large molecule therapeutics, including analysis using appropriate software applications (i.e WinNolin, Watson, etc.).

• Understanding of bioanalytical methods (ligand binding assays, mass spectrometry, or other biodistribution methodologies) to assess protein therapeutics PK and disposition 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 project teams.

• Excellent oral and written communication and presentation skills.

Salary Range: $158,000.00 - $206,780.00. Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

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