Scientist II/Senior Scientist, Pharmacologist

Reporting to the Senior Director of Pharmacology/Toxicology, the Scientist II/Senior Scientist will play a leading role in developing and executing the nonclinical strategy in support of Astellas Gene Therapy programs.

The successful candidate will directly influence the discovery and development of AAV-based gene therapies by designing, overseeing, and interpreting in vivo studies, and by serving as a Pharmacology/Toxicology representative on program teams.

This role has no laboratory responsibilities.

The successful candidate will partner with other scientists, clinicians, and external experts to advance transformational treatments for patients with severe genetic diseases.

Primary Responsibilities The Scientist II/Senior Scientist will be responsible for establishing the in vivo efficacy and safety of Astellas Gene Therapies’ drug candidates from early discovery through clinical development.

Design and oversee the execution of non-GLP and GLP outsourced studies with Contract Research Organizations, expert consultants, and academic laboratories.

Draft, review, edit and finalize non-GLP and GLP nonclinical study protocols, amendments and study reports, ensuring that documents meet regulatory and compliance requirements as well as program timelines.

Analyze, interpret, and summarize nonclinical data, present it to internal project and senior management teams, and to global health authorities.

Write, edit, and finalize nonclinical sections of regulatory documents and play a key role in interactions with global health authorities.

Provide scientific and strategic leadership as a member and/or leader of Research Project Teams, and work collaboratively in cross-functional teams.

Maintain a current understanding of pharmacology, toxicology and gene therapy literature and methodology, as well as the scientific literature related to the specific indications being supported.

Present results at scientific conferences and draft manuscripts for publication at peer-reviewed journals.

About you Must Have/Required PhD in a relevant life-science discipline with 2-5 years of pharmaceutical or biotechnology industry experience.

Demonstrated experience working with animal models and ability to design experiments aimed at predicting clinical outcomes.

Substantive experience working with biologics, preferably gene therapies.

Strong understanding of molecular biology techniques such as PCR, hybridization and blotting methods, immunoassays, sequencing, etc.

Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex results.

Familiarity with regulatory guidance in preparation for IND/CTAs.

Proven ability to work effectively and collaboratively on cross-functional teams, including leading and spearheading projects internally and externally.

Excellent oral, written presentation and communication skills.

Interest and willingness to travel to monitor outsourced studies.

Excited to work in a dynamic, fast-paced environment.

Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted