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- Philadelphia, PA
new job!

The Regulatory Affairs Associate, under general guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA, EMA and other health authorities within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include amendments, supplements, annual reports, DSURs and additional documents as needed. Compiles and reviews amendments, supplements, annual reports, etc., for FDA and other health authority submissions. Interacts....

- Philadelphia, PA
new job!

The Ocular Research Scientist is a member of the Ocular functional group within Translational Research. He/she will be responsible for:Design, execution and data analysis for ocular-directed research programs.Write study reports, manuscripts and present results at appropriate scientific meetings.Initiate and oversee joint programs with external collaborators. RESPONSIBILITIES:Hands-on execution of in vitro and in vivo experiments on the bench.Identify and validate new indication targets and....

- Philadelphia, PA
new job!

The Neuroscience Lead (or CNS) will manage the CNS functional group within the Discovery Research group under Translational Research. He/she will be responsible for: - Providing leadership within a group of scientists/research associates, to develop pre-clinical programs from early discovery to the clinic . - Initiate and oversee joint programs with academic collaborators. - Establishing project timelines and ensuring work is completed according to schedule. - Training and developing staff at....

- Philadelphia, PA
new job!

Member of the Human Resources team responsible for the execution of proactive recruitment strategies in order to attract key talent in line with corporate objectives. Will develop strong partnerships with internal and external customers, and build pipelines of qualified candidates to meet both existing and forecasted talent needs. Demonstrates and maintains a comprehensive understanding of the marketplace, while continuously building strong recruiting networks and developing innovative and....


Reporting to the Head of Discovery & Liver Research Lead, the Senior Administrative Assistant provides administrative support to the translational research department leaders in a fast-paced environment. The primary accountability is to ensure the needs of the executive and the department are prioritized, organized and executed in order to maximize their productivity. This is accomplished by coordinating the support of the various leaders, as well as routine departmental support as....

- Philadelphia, PA

The clinical trial assistant is responsible for providing broad support for clinical trial management. S/he will assist the clinical project managers and other members of the team with day to day clinical trial execution and maintenance activities. RESPONSIBILITIES: Clinical trial support:ensures study documents are tracked, file, maintained, and archived in audit-ready condition; maintains clinical trial masterfilesassists with handling queries from sites and provides site support as needed;....


The Senior Clinical Contracts Coordinator is responsible for providing support to the clinical operations group by coordinating the approval process for various clinical trial documents across all studies. S/he will assist the clinical project managers and other members of the team to facilitate timely approval of documents. RESPONSIBILITIES:Work across all studies and therapeutic areas to support clinical study teams.Work with Spark legal to identify acceptable alternative/fallback language....


As a member of the Clinical Operations Team, the Clinical Project Manager/Senior Clinical Project Manager designs, plans, implements and executes the overall direction of clinical projects from protocol development, selection and qualification of vendors/investigational sites, operationalization of study activities (startup through closeout) and finalization of clinical study reports. S/he will collaborate with cross functional teams to design and develop clinical study protocols, develop and....


The External Manufacturing & CDMO Lead will oversee and manage the Contract Development and Manufacturing Organizations (CDMOs) providing drug substance Manufacturing, final formulation, aseptic filling and packaging/labeling services for drug substance/drug product intended for commercial and/or clinical distribution. The incumbent will lead cross-functional programs to ensure a consistent approach across CDMO sites through formalized technology transfer procedures, standardized....

- Philadelphia, PA

The MS&T Engineer is a critical role within the Manufacturing Science and Technology (MS&T) Function supporting internal and external drug substance and drug product manufacturing. This individual has responsibility for developing and executing on a range of technical capabilities across the lifecycle of products that the team supports. These capabilities include Process Validation (incl. Continued Process Verification program administration), CMC Regulatory support, technical protocol


The Sr. Corporate Strategy Specialist is a cross-functional and hands-on position that is responsible for development of analytics to support strategic projects & inform execution of core business issues. This role will be responsible for strategic financial planning and modeling, including the Long Range Plan (LRP), competitive intelligence assessments and monitoring of adjacent or competing therapies across the product portfolio, as well as other analyses to support key company....


The Medical Science Liaison (MSL) will be responsible for providing non-promotional scientific, educational, and research support for Spark Therapeutic gene therapy portfolio in the respective territory. The MSL position is a field based member of the Medical Affairs team. The MSL should be highly trained in a health care field and well versed in clinical practice and basic science. The MSL should be able to deliver cutting edge data and technical/practical education to Health Care....


Provides ongoing administrative support to multiple members of a department in a fast-paced environment. The primary accountability is to ensure the needs of the function are prioritized, organized and executed in order to maximize productivity. This is accomplished by coordinating the support of the various leaders, as well as routine departmental support as requested. Daily items for assigned personnel include calendar management, scheduling of meetings, phone support, expense reports,....

- Philadelphia, PA

The primary goals of Analytical Sciences are: to lead the phase-appropriate optimization, qualification, verification and validation of analytical methods across the product development lifecycle from clinical to commercialization; provide support to QC in the investigation of non-conformances, invalid assays; and troubleshooting method problems. Analytical Sciences is also responsible for developing and overseeing a critical reagents program, the reference standard program, periodic review of


The Quality Control Coordinator will be responsible for samples receipt and management at the QC laboratories, as well as shipping samples to contract organizations. S/he will be responsible for coordinating internal testing, managing paperwork, compiling and archiving data package. S/he will assist in generating and revising GMP documents such as SOP and ensuring GMP-controlled copies are maintained within the laboratory. This person will be responsible for laboratory housekeeping, assist to....


Lead the development of US Hematology medical/scientific strategy and execution of core medical affairs activities such as health-care/provider interactions; educational initiatives (medical education, data, guidelines, and value proposition) and patient identification in support of hemophilia clinical program. Work closely with sales, marketing, and commercial teams to provide strategic medical input into core brand strategies, support medical/marketing activities, and market access. Provide....


This position is a key participant in the day-to-day operation and planning of rAAV vector production related work, with primary responsibility to execute established protocols of manufacturing research and pre-clinical grade rAAV vectors. The individual in the role will participate in (but not be limited to) manufacturing of rAAV vectors including cell culture, vector production and purification, and rAAV related assays. Additionally, the individual will contribute to the implementation of....

- London, United Kingdom

The Medical Affairs Lead – EU Hematology reports into our Medical Strategy Lead – Hematology, based in Philly.. You would be responsible for leading development and execution of EU-focused medical strategy and tactics, including disease state awareness activities, clinical data presentations, KOL engagement, market access support, and patient identification in support of Spark’s hemophilia program. You'll lead hematology-related medical support for the Regulatory and Clinical Development....

- Philadelphia, PA

The clinical trial liaison (CTL) is a specialized, field-based role exclusively focused on engaging investigative sites participating in clinical trials. The CTL serves as the consistent face of Spark and point of contact for a clinical trial or program and is responsible for providing support for clinical trial management. S/he coordinates communication between sites and the Sponsor/CRO and provides 1:1 support to each site as needed. The clinical trial liaison works with all the sites on the


The Senior animal research associate will be responsible for overseeing and performing in vivo studies to support all the therapeutic areas of the translational team. Responsible for the submission, amendment and continuation of IACUC protocols covering all small animal studiesPrimary interface with regulatory agencies for animal welfare and veterinarial staff within the animal facilitySupervise the current in vivo staff membersOversee and perform large numbers of in vivo studiesMaintain....

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