Denali Therapeutics · 14 hours ago
Associate Director, Clinical Pharmacology
South San Francisco, CA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$188K/yr - $283K/yr
7+ years expDenali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. The Associate Director in Clinical Pharmacology will develop and lead clinical pharmacology and modeling and simulation strategies for biotherapeutic and small molecule programs, guiding project teams from early development through late-stage clinical trials and regulatory submissions.
BiotechnologyGeneticsHealth DiagnosticsTherapeutics
Responsibilities
Independently develop and lead 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 and review clinical study designs and write study protocols, amendments, and reports that meet regulatory standards and project timelines
Lead and conduct hands-on advanced 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 management, regulatory authorities, and external conferences
Author and review sections of regulatory submissions, including IND/CTA and NDA/MAA/BLA filings
Mentor and/or manage junior team members fostering their professional development and contributing to team growth
Lead direct report(s), where applicable, through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement
May manage external vendors as needed
Qualification
Required
PhD or PharmD, or other advanced degree, in Pharmaceutical Sciences, Pharmacology, Pharmacokinetics, or a related scientific discipline
At or near 7 years of relevant work experience inclusive of postdoctoral work; or MS with 10+ years of relevant work experience
Strong understanding of PK/PD principles and regulatory expectations across all phases of development
Hands-on experience with quantitative analysis tools such as Phoenix WinNonlin, NONMEM, or similar software
Demonstrated success leading clinical pharmacology components of global development programs
Excellent written and verbal communication skills, with ability to present complex data to technical and non-technical audiences
Proven track record of collaboration within cross-functional drug development teams
Preferred
Experience in neuroscience, rare disease, or biotherapeutics development preferred
Benefits
401k
Healthcare coverage
ESPP
A broad range of other benefits
Company
Denali Therapeutics
Denali Therapeutics is dedicated to defeating neurodegenerative diseases to deliver safe and effective medicines to patients and families.
501-1000 employees
H1B Sponsorship
Denali Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (14)
2023 (7)
2022 (6)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.32BKey Investors
Royalty PharmaBaillie Gifford
2025-12-04Post Ipo Debt· $200M
2024-02-27Post Ipo Equity· $500M
2022-10-19Post Ipo Equity· $275M
Leadership Team
Ryan Watts
CEO
Peter Chin
Sr. Vice President & Head of Late-Stage Clinical Development and Medical Affairs
Recent News
2026-01-11
Longevity.Technology
2026-01-03
Company data provided by crunchbase