Senior Scientist, Clinical Pharmacology

Denali Therapeutics; South San Francisco (CA); On-site; USD 142,000 - 198,000; Full time

Job summary

An established industry player is seeking a Senior Scientist in Clinical Pharmacology to drive innovative therapies for neurodegenerative diseases. This pivotal role involves developing clinical pharmacology strategies, designing studies, and analyzing critical data to guide drug development from early stages through regulatory submissions. Join a collaborative team dedicated to scientific discovery and making a real impact on patient lives. If you are passionate about advancing therapeutics and thrive in a dynamic environment, this opportunity is tailored for you.

Benefits

401k

Healthcare Coverage

Employee Stock Purchase Plan

Diverse and Inclusive Environment

Qualifications

• 5+ years experience in Clinical Pharmacology and drug development.
• Proficiency in quantitative PK/PD data analysis tools.
• Strong analytical and communication skills for presenting complex data.

Responsibilities

• Develop Clinical Pharmacology and M&S strategies for biotherapeutics.
• Conduct hands-on PK and PD data analysis to support clinical decisions.
• Analyze and communicate PK/PD data to project teams and regulatory authorities.

Skills

Clinical Pharmacology

Pharmacokinetics

Pharmacodynamics

Quantitative PK/PD Data Analysis

Cross-Functional Collaboration

Neuroscience Background

Education

PhD in Pharmaceutical Sciences

PharmD

Tools

Phoenix WinNonlin

Job description

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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.

Key Accountabilities/Core Job 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.
  
  

Qualifications/Skills

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

Salary Range: $142,000.00 to $198,000.00 . 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.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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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