Fuji Film United States
Jan 18, 2019Full time
FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. We partner with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. Our technology can be used to create induced pluripotent stem cells (iPSCs) from anyone and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system result in inventoried iCell(r) products and donor-specific MyCell(r) Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development. FUJIFILM Cellular Dynamics, Inc. is seeking a Vice-President Development to lead our therapeutic program(s) development efforts. This newly created position is in our Madison, WI headquarters. The ideal candidate will have a strong background and knowledge of pharmaceutical development (preferred in the biologics space) with a proven track record of working with products from the IND submission, all the way to new drugs approval with a core focus on leading the programs to take right path.. External US. Job Functions. Facilitate the IND submission and clinical development of company's lead assets and foster efficient, high quality therapeutic programs based on the highest scientific, medical and regulatory standards.. Represent the company to outside parties and/or investigators as a person in charge for clinical development; organizes investigators meetings and conducts other relevant activities to support development objectives.. Ensure appropriate objectives are met and that company resources are effectively utilized to meet strategic product development plans by leading development of timetable, and budget and resource analysis for clinical programs and personnel administration.. Lead early stage pipeline programs, including process development, scale-up, technology transfer, clinical material manufacturing support, analytics, IND submissions, to support development of products leading to new drugs approval.. Lead identification and execution of program strategies and goals, developing optimized screening tiers, defining key Go/No-go criteria and managing matrix teams.. Manage departments' annual budgets and quarterly forecasting processes. Ensure sound management of head count and expenses to meet approved spending plan while achieving all departmental commitments and project objectives.. Review and edit content of development sections of IND, BLA, and other regulatory documents such as protocols and technical reports in collaboration with the development, quality, and regulatory groups to support regulatory filings. Pro-actively identify project issues and implement appropriate regulatory strategies to mitigate risks.. Support implementation of key standard processes that lead to positive and measurable impact for clinical programs managed by the clinical research team (e.g. quality, efficiency, consistency). Qualifications. Late stage experience, including process and product characterization, and validation toward new drug application and beyond.. Analytical with strong background in understanding of FDA, ICH and other regulatory requirements for CMC.. Understanding the way in which biologics therapeutics are being developed and advising the business on any new developments.. Depth of experience with development activities within department from IND enabling studies through clinical and BLA, while leading a team of Program Directors with significant scientific support resources.. Significant leadership contributions in bioprocess development, regulatory strategy, authoring and approval process.. FUJIFILM Cellular Dynamics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.. Glassdoor has millions of jobs plus salary information, company reviews, and interview questions from people on the inside making it easy to find a job that's right for you.