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About the Role
This role leads a dedicated DMPK team, providing scientific and strategic input to advance a portfolio of blood-brain-barrier penetrant biotherapeutics. The individual serves as a subject-matter expert and people leader, collaborating with cross-functional teams to shape PK, drug disposition, and translational pharmacology strategy.
Responsibilities
- Lead and manage a group within the Nonclinical Safety Assessment and DMPK organization, providing strategic, project-focused vision and oversight to advance drug candidates from Discovery through CTA/IND-enabling studies into early clinical development ultimately supporting BLA submission.
- Deliver on Project Team objectives by contributing scientific expertise in pharmacokinetics, drug disposition, biodistribution, and translational pharmacology/pharmacodynamics.
- Participate on Project Teams as a subject-matter expert, contributing to optimization and selection of lead clinical candidates, and support group members serving in this capacity.
- Design nonclinical PK/PD studies to answer translational questions supporting project deliverables and first-in-human dose predictions; oversee TK analysis for non-GLP and GLP toxicology studies.
- Lead Project Teams and Pharmacology Technical Teams through the CTA/IND-enabling stage of drug development.
- Serve on the Development Sciences Leadership Team, contributing to Functional and Organizational strategy including goal setting and staff development.
- Establish and maintain productive relationships with Discovery Sciences, Bioanalytical Sciences, Nonclinical Safety Assessment, Clinical Pharmacology, Quantitative Pharmacology, Translational Medicine, and Regulatory to advance projects to key decisions and development milestones.
- Analyze, interpret, and communicate data to project teams, senior management, global health authorities, and strategic partners.
- Author and review nonclinical and clinical sections of regulatory filings.
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance, and provide ongoing feedback on growth and development.
Requirements
- Typically requires a PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology/Toxicology, Engineering, or a related field.
- Typically requires 10+ years of relevant experience, including 8+ years of people management, mentorship, and coaching experience.
- Established expertise in biotherapeutic drug disposition and pharmacokinetics, with a track record identifying clinical candidates and advancing molecules through CTA/IND milestones to first-in-human trials.
- Proven ability to evaluate drug properties impacting PK, investigate PK/PD relationships, and apply relevant bioanalytical methods (ligand binding assays, mass spectrometry, or other methodologies).
- Demonstrated success leading and/or serving on cross-functional Project Teams, contributing to data-driven decision-making and drug development strategy.
Skills
- Pharmacokinetics
- Drug disposition
- Translational pharmacology
- PK/PD study design
- Bioanalytical methods (ligand binding assays, mass spectrometry)
- People management
- Mentorship
- Coaching
- Cross-functional team leadership
Location
- Remote
Work Type
- Full-time
Experience Level
- 10+ years of relevant experience
- 8+ years of people management experience
Education Level
- PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology/Toxicology, Engineering, or a related field
Salary/Compensations
- $212,000.00 to $276,000.00
Benefits
- 401k
- Healthcare coverage
- ESPP
About the Company
- Denali is committed to its core company value of unity by creating a diverse and inclusive environment.
Equal Opportunity
- Denali is proud to be an equal opportunity employer and does 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.