31 to 45 of 3,202
60% Manage all aspects of regulatory submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. Lead functional groups across the organization in the development of relevant data to complete regulatory submissions. Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelin
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The Bioanalytical Assay Lead will be part of the Pre Clinical Bioanalytics (PCB) group, supporting multiple fast paced non clinical studies for advancing novel gene therapy programs across all Therapeutic Areas. The position requires expert level knowledge in bioanalytical and biomarker assay development, preclinical sample testing, data analysis and technical troubleshooting. Utilize previo
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As the Talent Acquisition Lead, you will partner with senior management in the recruitment of talent to Spark’s Technical Operations function individually managing a portfolio of openings and focusing on meeting or exceeding client's expectations and ensuring a positive candidate experience. You will work with employees and managers in the client organization to assure that we have
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The Biosafety Specialist will primarily support the Biosafety Program in laboratories and other facilities operated by Spark. Assists the EHS Lead in the implementation of various elements of the Biosafety Program that supports the use of infectious agents, human materials, vectors, virus and other potentially hazardous biologic materials. Work includes the development, implementation and ev
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Reporting to the Chief Scientific Officer, the Chief of Staff (CoS) will contribute to all activities related to Research at Spark. This leader will be accountable to create the right structure and process to support decision making, process efficiency, communication flow, and innovation. The role will serve as a key advisor to the CSO and the Research leadership, acting as an integrator acr
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The Senior analytical Scientist position requires a strong background and hands on experience in developing, validating, and implementing various molecular biology and cell based assays to support the process development of gene therapy products across all therapeutic areas. The selected candidate will apply existing knowledge to the development of new assays and methods to support process develop
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Reporting to the Head of Pharmacovigilance, the Pharmacovigilance (“PV”) Patient Safety Lead will collaborate closely with the Head of PV to ensure Spark protects patients’ safety by providing safety support for products in various stages of clinical development and follow them through their lifecycle and commercialization. S/he will serve as the medical safety lead for PV
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The Global Medical Affairs Therapeutics Area Leader, Hematology is a critical member of the Medical Affairs leadership team and is responsible for defining the global Medical Affairs vision, strategies & tactics that support Spark’s late stage hematology product development and commercialization objectives. They will lead efforts in key opinion leader (KOL) identification and developme
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The Molecular Engineering Research Lead will manage one or more research programs as part of the Discovery group within Translational Research. S/he will be responsible for expanding and/or developing novel capabilities related to directed evolution and molecular design. Directing and overseeing discovery programs, facilitating translation from in vitro through in vivo proof of concept in sm
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The Benefits Lead will provide comprehensive oversight and strategic input into all of Spark’s benefits programs including implementation, administration, communications and education. The Lead will provide research, analytical support and recommendations into the design and implementation of Spark’s Total Rewards programs and vendors focusing on health, welfare and retirement/40
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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 de
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The Compensation Lead will provide strategic planning, design and implementation of all aspects of our compensation programs including base pay, cash incentive plans, long term incentive plans, job leveling and executive compensation. The role is responsible for administration, communications and education of these programs. The Lead will provide research, analytical support and recommendati
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The Regulatory Affairs Lead, 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 may include INDs/CTAs, amendments, annual reports, DSURs, briefing documents, orphan drug applications, and additional
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The Head of Clinical Operations is responsible for overall management of the Clinical Operations function which includes clinical program management and clinical supply. S/he will be responsible for leading the Clinical Operations function to advance our gene therapy portfolio across a wide range of genetic disorders. S/he will assume responsibility for both the strategic and tactical execut
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The Research Scientist is a key member of the CNS Discovery Research Group and participates in the development of Spark’s CNS targeted gene therapy products. She/he will actively participate in the development of novel targets, facilitating translation from in vitro through in vivo proof of concept Responsibilities He/she will be responsible for Collaborating with other Translatio
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