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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.
We don't follow footsteps. We create the path.
Primary Duties
The Regulatory Diagnostic Lead will be the regulatory diagnostic subject matter expert at Spark and will work to lead and deliver on global diagnostic regulatory strategy as an integrated part of the global regulatory strategy for the Gene Therapy. The Regulatory Diagnostics Lead will support developmental and post-approval projects as assigned. The lead will provide strategic regulatory diagnostics input to project teams for assigned programs. This role is responsible for leading/managing global regulatory plans to support a precision medicine approach (e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies. The Regulatory Diagnostic Lead works to lead interactions with FDA and other Regulatory Authorities, to validate regulatory diagnostic strategy, and to ensure compliance of diagnostic strategy programs with regulatory requirements for diagnostics and devices. The Regulatory Diagnostic Lead will provide global strategic input on key development documents including (but not limited to) clinical protocols, study reports, SRDs etc. The Lead will develop and/or contribute to global strategies to support planned submissions e.g. IDEs, INDs, CTAs, PMAs etc. and be responsible for ensuring compliance with applicable global and regional regulations e.g. IVDR. Provides guidance on planning, writing, review of key dossier documents for submissions globally. The Regulatory Diagnostic Lead will also be responsible for recommending strategies for earliest possible approvals of diagnostics and devices in support of clinical trials and marketing authorization applications, and will combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured and/or distributed to meet the required legislation in the target market.
Responsibilities
Education and Experience Requirements
Key Skills, Abilities, and Competencies
Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $150,100 to $225,100.
Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.
Full Time
Hospital
$77k-101k (estimate)
03/07/2024
05/12/2024
sparktx.com
PHILADELPHIA, PA
200 - 500
2013
Private
ELIZABETH JOHNSTON
$50M - $200M
Hospital
Spark Therapeutics develops gene therapies for the treatment of hemophilia and neurodegenerative diseases.