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

Required Qualifications

• PhD with 7 years, MS with 10 years, or BS with 12 years of pharmaceutical, biotechnology or specialized CRO industry experience in a similar nonclinical role, and 5 years of experience with animal models and designing experiments for biologics

• Strong knowledge of nonclinical testing guidelines to support clinical development and registration filings

• Familiarity with product quality, bioanalytical assay development and validation

• Knowledgeable in developing IND testing programs and in preparing IND and BLA/MAA filings

• Strong study management track record showing clear proficiency in nonclinical project management skills

• Demonstrated working knowledge of GLP and GMP regulations

• Excellent oral, written presentation and communication skills

• Strong knowledge of enterprise management software (EMS) systems for tracking and archiving of study documents, as well as basic statistics, and understanding of SEND requirements for regulatory filings of animal studies

• Demonstrated ability to recruit, mentor and manage direct reports

Preferred Qualifications:

• Experience with genetically based animal models of disease, including establishment of novel lines and developing colonies of animals for use in research studies.

• Understanding of gene therapy and/or novel biologics concepts and methodology, as it relates to nonclinical study design and analysis.

• Experience in a high-growth, fast-paced environment.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 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