Dir, NonClinical Study Management
Astellas

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence 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. For more information, please visit our website: www.astellasgenetherapies.com

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

• Be BOLD (Find a Way)
• Care Deeply -- for our patients, each other and our work
• #GSD (Get Stuff Done)THE ROLE

The primary goal of the Director Nonclinical Study Management is to develop and execute the nonclinical strategy for Astellas Gene Therapies (AGT). Leveraging and harnessing AGT's core competencies in AAV gene therapy, the role is responsible for overseeing and monitoring animal studies in orphan indications including inherited muscular disorders, congenital CNS diseases, retinal and ophthalmic degenerative diseases, and other inherited diseases. The Director of Nonclinical Study Management will lead the Study Management Group.

Essential Job Responsibilities:

• Responsible for overseeing contracting and monitoring all non-GLP and GLP outsourced nonclinical studies with Contract Research Organizations (CROs), expert consultants and academic collaborators
• Leads, supervises, and mentors the Study Management Group
• Reviews, edits, and finalizes GLP and non-GLP nonclinical study protocols, amendments, and study reports ensuring that documents meet global regulatory and compliance requirements and project timelines
• Oversees the preparation nonclinical sections of regulatory documents and filings and plays a key role in the development of these sections for regulatory submissions
• Analyzes, interprets, and summarizes nonclinical safety data to be presented to internal project and senior management teams
• Represents the interests and importance of the Nonclinical Study Management Group before senior management and other functional groups
• Oversees and manages the budget associated with the conduct of animal studies externally
• In close collaboration with scientists in Research, develops and assesses safety biomarkers and PK/PD/safety analyses into the overall nonclinical development plan for Astellas Gene Therapies programs
• Maintains a current understanding of pharmacology and toxicology literature and methodology, as well as the scientific literature related to the specific drug discovery projects
• Performs routine oversight at CROs with minimal supervision, ensuring adherence with the study protocol and GLP compliance
• Acts as primary Study Monitor on non-GLP and or GLP studies conducted at CROs
• Manages and oversees documentation and data management/archiving for Pharmacology Toxicology

---