Senior Scientist, Clinical Pharmacology
Denali Therapeutics
Full-time
Remote friendly (South San Francisco, CA)
United States
$142,000 - $198,000 USD yearly
Clinical Research and Development
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Role Summary
Senior Scientist, Clinical Pharmacology. Develop clinical pharmacology and modeling and simulation strategies for biotherapeutic and small molecule programs, guide project teams from early development through late-stage clinical trials and regulatory submissions. Design and execute clinical studies, analyze PK/PD data, and collaborate with cross-functional teams to advance therapies for neurodegenerative diseases.
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
- 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.
Skills
- Quantitative PK/PD analysis
- Clinical pharmacology strategy development
- Regulatory submission preparation
- Cross-functional collaboration
- Communication of complex data
Education
- PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related field