Associate Director, Clinical Pharmacology
Associate Director, Clinical Pharmacology
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
Denali Therapeutics is seeking to recruit an experienced Associate Director to join the Clinical Pharmacology team. The candidate will have hybrid responsibilities as a Clinical Pharmacologist and a Pharmacometrician and will support Denali’s biologics and small molecule programs in clinical development. The candidate will act as a subject matter expert as the Clinical Pharmacology lead on cross-functional project teams and will work in close collaboration with Denali colleagues in Development Sciences (Drug Metabolism and Pharmacokinetics, Quantitative Pharmacology, Nonclinical Safety), Early- and Late- Clinical Development, and Translational Sciences. S/he will be responsible for the development and execution of clinical pharmacology plans and for quantitative analyses to support the company’s drug development strategy. This position will report to the Head of Clinical Pharmacology.
- Develop and lead Clinical Pharmacology and M&S strategies and plans for biologics and small molecule drug candidates from pre-IND and first-in-human to all later phases of clinical investigation, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.
- Develop clinical study designs and write relevant sections of study protocols, study reports, Investigator Brochures, IND/CTA filings and NDA/MAA/BLA submissions, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.
- Independently conduct hands-on quantitative PK and PD analyses, including NCA, population PK/PD, and exposure-safety analyses, to support project needs for early-clinical stage programs.
- Select and manage pharmacometrics vendors conducting population PK/PD and exposure-response analyses in support of regulatory submissions for late-clinical stage programs.
- Analyze, interpret, summarize, and communicate data to internal project teams, senior management, global health authorities, and strategic partners.
- Contribute to building Pharmacometrics capabilities (e.g., trainings, incorporating new tools, etc.) and mentoring junior scientists within Development Sciences.
- PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related scientific discipline, with 6 or more years of relevant experience in Clinical Pharmacology or Pharmacometrics and drug development in the pharmaceutical industry (or equivalent)
- Experience leading design and implementation of Clinical Pharmacology and M&S strategies for biologics and small molecules.
- Hands-on experience performing quantitative analyses (e.g., population PK/PD, exposure-safety, exposure-efficacy, concentration-QTc) using standard pharmacometrics software (e.g., NONMEM, R).
- Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and communicate complex scientific information clearly and effectively.
- Strong oral, presentation, and written communication skills.
- Demonstrated ability to work effectively and collaboratively on cross-functional project teams.
- Experience with regulatory agency interactions and submissions (NDA, ANDA, BLA) preferred.
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 Range: $188,00 to $223,000. 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.