Associate Director, Clinical Pharmacology

Denali Therapeutics•South San Francisco, CA

4d•$188,000 - $283,000

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 Associate Director in Clinical Pharmacology will develop and lead clinical pharmacology and modeling and simulation (M&S) strategies for biotherapeutic and small molecule programs, and 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 leading and collaborating with cross-functional teams to advance therapies for neurodegenerative diseases. This role is within the Quantitative and Clinical Pharmacology (QCP) team in the Development Sciences function.

Requirements

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.

Nice To Haves

Experience in neuroscience, rare disease, or biotherapeutics development preferred.

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.