As a senior member of the Clinical Research and Development Team, the Clinical Operations Lead is responsible for the overall management of one or more programs within the Clinical Operations function, including the implementation, execution and completion of all departmental clinical trials and site selection and management. S/he will also assist (as needed) in development of new programs and departmental initiatives and participate in strategic planning activities throughout the organization. S/he will also be responsible for oversight of studies including but not limited to those for certain liver-directed and CNS programs; this includes designing, planning and implementing overall direction of clinical projects from protocol development, selection and qualification of external service providers/investigative sites through finalization of clinical study reports. S/he will manage the project activities including but not limited to: clinical monitoring, data management, statistical analysis, medical writing, safety monitoring and compliance to insure proper conduct and timely completion of all projects. S/he will be responsible for oversight and management of clinical operations project teams and personnel for the respective programs and will interact with the respective Asset and Brand Strategy teams.
Manage all clinical aspects of the program including:
Plan, execute and manage all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines;
Design and develop (but not limited to) the following program-specific documentation:
clinical development plan; integrated project plan
program timeline and budget
risk management plan
KOL/advocacy engagement plan
Design and develop (but not limited to) the following study-specific strategy tools and processes:
A balance of scientific and operational/project management and team leadership expertise
Ability to build effective relationships across, up and down the organization.
Experience in operationalizing clinical trials in Rare Disease.
Employer will assist with relocation costs.
About Spark Therapeutics
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies... are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
Challenge the inevitability of genetic disease by discovering, developing and delivering treatments in ways unimaginable – until now.
A world where no life is limited by genetic disease.