What are the responsibilities and job description for the Principal Scientist, Clinical Pharmacology position at Denali Therapeutics Inc?
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.
Key Accountabilities/Core Job 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.
May manage external vendors as needed.
Qualifications/Skills:
PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related fields with at or near 7 years of 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, exposure-response analysis, PBPK).
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.
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.
Salary : $165,333 - $204,000
