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.
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.
Be BOLD (Find a Way)
Care Deeply -- for our patients, each other and our work
#GSD (Get Stuff Done)
The Senior Manager, Immunotoxicologist reports into the Senior Director, Safety Assessment and be a vital contributor to the team. The successful candidate will have the opportunity to support the progression of AAV-based gene therapy programs with a focus on investigating immunological changes that may result from the transduction of host target cells, the expression therapeutic proteins and modality itself. As a member of the Research Department, the Senior Manager, Immunotoxicologist will play a critical role in developing, implementing and executing the nonclinical and clinical strategies for Astellas Gene Therapies' programs. The successful candidate will partner with internal scientists, clinicians and external experts to advance transformational treatments for patients with severe genetic diseases.
The Immunotoxicologist will participate in the design, execution, data analysis and interpretation of animal studies.
Communicate study results and their relevance to program teams, collaborators, senior management and regulatory agencies.
Review and draft relevant sections of regulatory submission documents such as CTAs, INDs, IBs and BLAs.
Collaborate with various Astellas Gene Therapies functions, CROs, academic or analytical laboratories to ensure the conduct and completion of high-quality studies and timely progression of programs.
Lead research regarding safety risks induced by immune response to AAV including innate immunity, acquired immunity, complement activation, pre-existing immunity, and treatments with IgG degraders.
Implementation of assay system for immunotoxicology optimization
The Immunotoxicologist will be encouraged to lead pre-clinical stage gene therapy program teams.
Comprehensive knowledge of immunotoxicology
PhD with 7+ years of immunology research experience working in pharmaceutical, biotechnology or CRO companies.
Experience in the design, conduct and interpretation of GLP and non-GLP nonclinical studies.
Strong understanding of drug discovery, development and regulatory processes.
Evidence of supporting drug discovery/development programs across important milestones such as first-in-human dosing.
Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex results.
Proven ability to work effectively and collaboratively on cross-functional teams, including leading and spearheading projects internally and externally.
Excellent oral and written communication skills.
Up to 10% travel.
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
Experience working with gene therapy programs.
Experience working with rare disease indications.
Salary Range: $129,800-173,000 (NOTE: Final salary could be more or less, based on experience)
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