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 Director, Quantitative Pharmacology within the Quantitative and Clinical Pharmacology sub-function in Development Sciences to develop and execute modeling and simulation (M&S) strategies supporting preclinical translational pharmacology efforts and all stages of clinical development. The incumbent will play an important part in advancing Denali’s portfolio of novel blood-brain-barrier penetrant transport vehicle (TV) biotherapeutics, including oligonucleotide transport vehicle (OTV) clinical candidates, and small molecule programs in clinical development.

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.

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.
• Excellent oral, presentation, and written communication skills. 
• Experience with regulatory interactions and submissions (NDA, ANDA, BLA).

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.

Salary Range: $223,00 to $253,333. 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 athttps://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.

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