Non-Clinical Study Manager

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.

Requirements

Qualifications

• MS with 5+ years or BS with 7+ 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.
• Experience with technical protocol, report, and submission writing
• 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

Preferred Qualifications :

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 drafting non-clinical sections of IND / CTAs

Working Environment

At Astellas we recognize the importance of work / life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.

We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Salary Range : $114,800 - $153,000 (NOTE : Final salary could be more or less, based on experience)

Benefits :

• 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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.