About Astellas Gene Therapies Astellas Gene Therapies (AGT) is a leading AAV-based genetic medicines company focused on developing and commercializing innovative gene therapy products.
AGT was created April 1 st , 2021.
We have a highly attractive set up building on a highly innovative biotech culture with the stability and investment in research and manufacturing by a major pharma.
Research is led from South San Francisco with staff also in Tokyo.
We have a promising pipeline including two clinical programs and several others on the way.
We focus primarily on neuromuscular, CNS and eye diseases.
AGT is a focused, experienced and passionate team driven to improve the lives of patients.
AGT leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues.
Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.
The Role We are in search of a Senior Immunotoxicology Manager that will be the lead subject matter expert on immune-related toxicity and pathology for AGT preclinical programs and will be involved in clinical development activities as well.
This leader will play a critical role in delivering the AGT portfolio and will further develop the AGT immune-toxicology strategy.
This leader will play a key role in planning and evaluating pre-clinical studies as well as clinical studies for AGT gene therapy candidates providing key input on potential immune-related toxicity and pathology.
Responsibilities include supporting designing, analyzing and reporting on in vitro and in vivo toxicology and pathology studies with a particular emphasis on immune-mediated safety of gene therapy clinical candidates.
The role requires effective networking with project teams and other groups within AGT Research particularly other groups within Integrative biology, AGT TechOps, regulatory, clinical development and other Astellas functions.
Responsibilities Be an active member of the AGT Research organization with a shared responsibility for developing and delivering clinical candidates for the Company’s gene therapy pipeline.
Oversees development of an AGT immuno
– toxicology strategy Plays key role in planning and evaluating pre-clinical studies as well as clinical studies providing key input on potential immune-related toxicity and pathology.
Plays a key role as a team member or lead in developing a root cause analysis for SAEs leading to clinical hold.
This includes participation in Scientific task forces.
Design immune-toxicology studies and ensure that they are conducted in compliance with relevant SOPs, regulatory requirements, GLP (where required) and the highest quality standards.
Evaluate data quality and study progress on an ongoing basis, inform management of potential issues, develops solutions and works with the team on corrective action plans.
Ensure appropriate maintenance of nonclinical documents.
Represent Immuno-toxicology perspectives on cross-functional project teams for strategic planning, risk/benefit assessments and achievement of company, project and team goals.
Occasional travel to partners and vendors.
Required Qualifications 3 years in the biotech/pharma industry with PhD in immunology or related area of life sciences.
Strong scientific track record documented in scientific publications.
Deep experience in toxicology and pathology related to immunological processes A transparent, flexible, can-do approach to address issues innovatively and proactively to promote teamwork and a pleasant work environment.
Outstanding influencing, oral and written communication skills.
Must be a team player.
History of success working with all levels in a dynamic fast paced hands-on environment.
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 Experience with safety assessment and pharmacology of gene therapy products Experience with rare diseases, neuromuscular, CNS and/or eye diseases Experience writing/reviewing regulatory sections of IND.
Comprehensive knowledge of the drug development process including cross functional integration from animal pre-clinical POC through Phase I.
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 Research and Development Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans