Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
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.
The Role
The primary purpose of the Nonclinical Study Manager is to select Contract Research Organizations (CROs) and monitor non-GLP and GLP-outsourced nonclinical studies for Astellas Gene Therapies (AGT) programs. Leveraging and harnessing AGT core competencies in AAV gene therapy, the Nonclinical Studies Manager will be responsible for executing the AGT strategy in several disease indications. The Study Manager will work cross-functionally with internal program teams and CROs.
Responsibilities
Primarily responsible for selecting, contracting, and monitoring non-GLP and GLP nonclinical studies with Contract Research Organizations (CROs), expert consultants and academic collaborators. Review, edit, and finalize non-GLP and GLP nonclinical study protocols, amendments, and reports, ensuring that documents meet project timelines, expectations, and deliverables, as well as global regulatory and compliance requirements. Writes, edits, and finalizes nonclinical sections of regulatory documents and plays a key role in interactions with global health authorities Through close collaboration with scientists in AGT Research, summarize nonclinical proof-of-concept and safety data, and present results to internal project and senior management teams. Maintain awareness and understanding of current key AAV based publications and related mechanisms. Understanding of general in vivo AAV pharmacology and toxicology best practices. Provides CRO oversight, ensuring protocol and GLP compliance adherence for proper study execution. Responsible for data management and document archiving of nonclinical studies. Advance the practice of Good Research Practices within AGT. Performs other duties as assigned or special projects as needed.