Director, Clinical Pharmacology
Apply NowCompany: Denali Therapeutics
Location: South San Francisco, CA 94080
Description:
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 Director in Clinical Pharmacology will lead and drive clinical pharmacology and modeling and simulation (M&S) strategies for biotherapeutic 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.
Key Accountabilities/Core Job Responsibilities:
Qualifications/Skills:
Salary Range: $200,000.00 to $253,333.00 . 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.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.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
The Director in Clinical Pharmacology will lead and drive clinical pharmacology and modeling and simulation (M&S) strategies for biotherapeutic 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.
Key Accountabilities/Core Job Responsibilities:
- Provide strategic and scientific leadership for Clinical Pharmacology and M&S strategies across multiple programs within a therapeutic area or modality from pre-IND through late-stage clinical studies, including pivotal Phase 2/3 trials and NDA/MAA/BLA submissions.
- Develop, review, and lead scientific strategy for clinical study designs, 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, regulatory authorities, and external stakeholders, and represent Clinical Pharmacology in governance meetings and strategic discussions.
- Author and review sections of regulatory submissions, including IND/CTA and NDA/MAA/BLA filings.
- Provide scientific mentorship and/or manage team members, fostering scientific excellence and contributing to team capability and 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.
- Manage external vendors as needed.
Qualifications/Skills:
- PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology (or related field), and at or near 10 years of overall 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 pharmacometrics is a plus.
- Experience developing Clinical Pharmacology and M&S strategies, preferably in biotherapeutics and in neuroscience or oncology indications.
- Strong analytical and communication skills for presenting complex PK/PD data.
- Proven ability to collaborate effectively on cross-functional teams.
Salary Range: $200,000.00 to $253,333.00 . 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.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.