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
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.
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 primary purpose of the Nonclinical Study Manager is to select 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 Contract Research Organizations (CROs).
Primarily responsible for selecting, contracting, and monitoring non-GLP and GLP-outsourced 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.
Review nonclinical sections of regulatory documents and filings for global health authorities.
In close collaboration with scientists in Research, summarize nonclinical proof-of-concept and safety data, and present them to internal project and senior management teams.
Maintain a current understanding of pharmacology and toxicology literature, as well as the scientific literature related to indications and platforms pursued by AGT.
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.
MS with 3+ years or BS with 5+ years of pharmaceutical, biotechnology or CRO industry experience in a nonclinical role.
Familiarity with product quality, bioanalytical assay development and validation.
Strong study management track record excelling in nonclinical project management skills.
Detail oriented with a good working knowledge of GLP regulations.
Excellent oral, written presentation and communication skills.
Excellent interpersonal, organizational and problem-solving skills required to manage multiple studies at different phases.
Understanding of animal welfare regulations (IACUC, USDA, and OLAW).
Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
Hands-on experience with in vivo studies, including dosing, animal care, and tissue collections; LAT or LATG certification preferred.
Understanding of gene therapy and/or novel biologics concepts and methodologies, in particular as they relate to nonclinical study design and data analysis
Experience with technical protocol, report, and submission writing
Salary Range: $ 99,000-132,000 (NOTE: Final salary could be more or less, based on experience)
Remote work from certain states may be permitted in accordance with AGT’s Responsible Flexibility Guidelines.
Some travel required to monitor outsourced studies.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Gene Therapy Research & Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans