Denali Therapeutics
Senior Scientist, Clinical Pharmacology
Denali Therapeutics, South San Francisco, California, us, 94083
Overview
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Senior Scientist, Clinical Pharmacology
role at
Denali Therapeutics .
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. This position is based in San Francisco, CA.
The Senior Scientist in Clinical Pharmacology will develop clinical pharmacology and modeling and simulation (M&S) strategies for biotherapeutic and small molecule programs, 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) and pharmacodynamic (PD) data, and collaborating with cross-functional teams to advance therapies for neurodegenerative diseases. This role is within the Quantitative and Clinical Pharmacology (QCP) team within the Development Sciences function.
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/Skills
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.
Salary, Benefits, and Company Information Salary Range: $142,000.00 to $198,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers.
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.
Equal Opportunity 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.
Job Details
Seniority level: Not Applicable
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
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Senior Scientist, Clinical Pharmacology
role at
Denali Therapeutics .
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. This position is based in San Francisco, CA.
The Senior Scientist in Clinical Pharmacology will develop clinical pharmacology and modeling and simulation (M&S) strategies for biotherapeutic and small molecule programs, 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) and pharmacodynamic (PD) data, and collaborating with cross-functional teams to advance therapies for neurodegenerative diseases. This role is within the Quantitative and Clinical Pharmacology (QCP) team within the Development Sciences function.
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/Skills
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.
Salary, Benefits, and Company Information Salary Range: $142,000.00 to $198,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers.
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.
Equal Opportunity 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.
Job Details
Seniority level: Not Applicable
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr