Director, Pharmacometrics/PKPD

Why Work for US

Are you ready to use your experience and expertise to make an impact on patients' lives? Audentes is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Audentes Therapeutics

Audentes Therapeutics, an Astellas company, is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

Our Values:

• Be BOLD (Find a Way)

• Care Deeply -- for our patients, each other and our work

• #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Reporting to the Senior Director, Pharmacology and Toxicology, the Associate Director/Director, Pharmacometrics will be a PhD-level scientist with a minimum of 6 years of industry experience. The successful candidate will have the opportunity to develop and test novel approaches to characterize and quantify the pharmacokinetic and pharmacodynamic aspects of AAV-based gene therapy. The Associate Director will use animal data and quantitative tools to better understand and predict the transduction, biodistribution and transgene protein expression profiles of various gene therapy candidates. As a member of the Research function, the Associate Director/Director in Pharmacometrics will play a critical role in developing and executing the nonclinical and clinical strategies for Astellas Gene Therapies programs.

Primary Responsibilities

• Partner with in vivo translational and bioanalytical scientists to design and analyze nonclinical studies and help elucidate the relationship between vector-gene administration and measures of efficacy and safety. The incumbent will analyze data, interpret results, develop predictive models and provide guidance to project teams.

• Serve on project teams as the pharmacometrics SME throughout candidate selection, nonclinical proof-of-concept, IND-enabling, and clinical development phases.

• Provide statistical support for study design, study power and significance testing.

• Devise dosing schemes, select sample collection timepoints and establish dose-response relationships.

• Perform modelling, including allometric analysis, to understand the translation of PK/PD data across animal species, including humans.

• Propose first-in-human doses based on PK/PD analysis of animal data.

• Advance clinical candidates; review and draft nonclinical and/or clinical pharmacology sections of regulatory (IND/CTA/BLA) filings and contribute to clinical protocol development.

About you

Must Have/Required

• A PhD in Pharmaceutics, Pharmacometrics, Pharmacology, Bioinformatics, Computational Biology or a related field, with a minimum of 6 years of industry experience

• Experience using and maintaining software platforms such as Phoenix WinNonLin, R, MATLAB/Simulink, NONMEM or other relevant data analysis and simulation programs

• Experience performing sophisticated statistical analysis

• Experience performing PK/PD analysis, in particular with large molecules

• Solid understanding of pharmacokinetic and pharmacodynamic principles, as well as the drug development process

• Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex results

• Ability to work effectively and collaboratively on cross-functional teams

• Excellent oral and written communication skill.

• Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

May Have/Preferred

• Experience working with gene therapy.

• Experience with rare-disease indications.

#LI-SS

Category PKPD

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans