About Astellas Gene Therapies
Astellas Gene Therapies (AGT) is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. AGT was created after the acquisition of Audentes Therapeutics. We have 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. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of 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.
Reporting to the VP and Head of Research, the Senior Director, Integrative Biology will be the senior in vivo scientist in the pre-clinical research organization overseeing pharmacology and toxicology experiments. This leader will play a critical role in delivering the AGT portfolio. A key responsibility will be to oversee and strengthen a world class team of 15 - 20 staff comprised of four functions Pharmacology, Toxicology, Study Management and Pharmacometrics & Statistics. The leader will be responsible for strategic leadership including design and coordination of all animal experiments outsourced to CROs or in academic collaborations. Responsibilities include analyzing and reporting on animal pharmacology, pharmacokinetic, and toxicology studies aimed at proving efficacy and safety of gene therapy clinical candidates. Additionally the role includes responsibility for study data management/ cross-department presentation of relevant data, coordinating animal studies and corresponding report writing.
* Be an active member of the AGT Research Leadership Team with shared responsibility for developing and delivering clinical candidates for the Company's
* Strong strategic and proactive leadership of the newly created Integrative Biology Department team of scientists to advance the Company's gene therapy pipeline.
* Oversee development of overall pharmacology and toxicology strategy for each program and play a leading role in ensuring high scientific standards for our animal studies.
* Accountability for management of the Integrative Biology budget.
* Ensure that nonclinical studies are managed and executed in accordance with established timelines and project plan within budget and.
* Design nonclinical studies and ensure that they are conducted in compliance with relevant SOPs, regulatory requirements, Good Laboratory Practices 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.
* Oversee the selection and management of nonclinical vendors. Negotiate contracts and budgets with sites and vendors.
* Ensure appropriate maintenance of nonclinical documents.
* Liaise with other departments to coordinate and plan for the availability of nonclinical supplies necessary to meet study requirements.
* Represent Pharmacology and Toxicology on cross-functional project teams for strategic planning, risk/benefit assessments and achievement of company, project and team goals.
* Develop and continually improve departmental infra-structure including development of SOPs.
* Occasional travel to partners and vendors.
* 10+ years in the biotech/pharmaceutical industry with PhD in Pharmacology, Toxicology or other biological sciences, or equivalent.
* Exceptional leadership skills and 5+ years of experience managing Scientists and Research Associates in industry.
* Strong scientific track record documented in scientific publications
* Demonstrated experience coordinating conduct of in vivo studies.
* Experience in pharmacokinetics, toxicology and animal pharmacology/monitoring animal studies.
* Successful experience writing/reviewing regulatory sections of IND.
* In depth experience managing CROs to achieve nonclinical milestones on time and within budget.
* Comprehensive knowledge of the drug development process including cross functional integration from animal pre-clinical POC through Phase I.
* 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 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.
* Experience with rare diseases, neuromuscular, CNS and/or eye diseases and/or gene therapy products.
* Experience from both biotech as well as pharma environment an advantage
* 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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled