Senior Scientist, Clinical Pharmacology

Denali Therapeutics • South San Francisco, CA

115d • $142,000 - $198,000

About The Position

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Senior Scientist in Clinical Pharmacology will develop clinical pharmacology and modeling and simulation (M&S) strategies for biotherapeutic and small molecule programs, guide project teams from early development through late-stage clinical trials and regulatory submissions. This role involves designing and executing clinical studies, analyzing pharmacokinetic (PK)/pharmacodynamic (PD) data, and collaborating with cross-functional teams to advance therapies for neurodegenerative diseases. This role is within the Quantitative and Clinical Pharmacology (QCP) team within the Development Sciences function.

Requirements

• PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related scientific discipline with 5+ years experience in Clinical Pharmacology and drug development; may include relevant postdoctoral experience.
• Proficiency in quantitative PK/PD data analysis tools (e.g., Phoenix WinNonlin, population PK analysis, exposure-response analysis, and/or PBPK modeling).
• Experience in developing Clinical Pharmacology and M&S strategies, with biotherapeutics experience preferred.
• Strong analytical and communication skills for presenting complex PK/PD data.
• Proven ability to collaborate effectively on cross-functional teams.

Nice To Haves

• Background in neuroscience indications and/or oligonucleotide drug development preferred.

Responsibilities

• Develop Clinical Pharmacology and M&S strategies for multiple biotherapeutics and small molecule programs from pre-IND through late-stage clinical studies, including pivotal Phase 2/3 trials and NDA/MAA/BLA submissions.
• Develop clinical study designs and write study protocols, amendments, and reports that meet regulatory standards and project timelines with minimal supervision.
• Conduct hands-on pharmacokinetic (PK) and pharmacodynamic (PD) data analysis using advanced tools and methodologies to support clinical decision-making.
• Analyze, interpret, and communicate PK/PD data to project teams, senior leadership, and regulatory authorities.
• Author and review sections of regulatory submissions, including IND/CTA and NDA/MAA/BLA filings.

Benefits

• 401k
• healthcare coverage
• ESPP
• broad range of other benefits

What This Job Offers

• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees