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Non Clinical Outsourcing Lead

Date: Apr 22, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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 challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

The Non-Clinical Outsourcing Lead will be responsible for coordinating the implementation of nonclinical studies and associated activities by interfacing with the Contract Research Organizations (CROs) to provide initial study designs, obtain project estimates, assist with the development of study protocols, assist Study Monitors with the logistical components of all nonclinical studies, and ensure alignment with internal development team timelines.

 

Responsibilities will include:

 

  • Identification and onboarding of CROs
  • Coordinate Animal procurement and screening
  • Assist Study Directors with the logistical components of all nonclinical studies, and ensure alignment with internal development team timelines
  • Interact directly with external client service representatives, management and other key personnel (e.g., Study Directors) at multiple Contract Research Organizations (CROs) for study coordination, initial protocol development, coordinating research report review, and defining project timelines
  • Act as primary contact for Spark to ensure consistent practices across vendors, groups and sites.
  • Track and forecast activities to ensure Company priorities are met.
  • Communicate and trouble-shoot  animal vendor/CRO issues
  • Assist in obtaining quotes from CROs for pending nonclinical studies or support services, including providing detailed study designs for Request For Proposals
  • Maintain complete, organized, accessible, and current study files including study schedules, contracts, protocols, and other applicable documents and correspondence
  • Assist investigators (e.g. study directors, study monitors, principal investigators, etc.) with preparation, review and circulation of study documents

 

Responsibilities:

 

50%  

  • Coordinate and oversee all animal procurement and screening for external nonclinical studies
  • Assist therapeutic area scientists in CRO selection
  • Assist therapeutic area scientists in preparation of SOW and POs
  • Organize study tracking documents for all outsourced studies

 

30% 

  • Directly Interact with CROs to coordinate studies

 

20%  

  • Interact with Therapeutic Area leads/Scientists to identify outsourcing needs

 

 

Requirements:

 

  • B.S/M.S/PhD in Biology or related field required
  • Generally has 5+ years of related experience with in vivo studies in biotechnology/pharmaceutical industry or contract research organization
  • Extensive experience and knowledge of in vivo procedures is required.
  • Experience interacting with CROs is required.
  • Understanding of gene therapy in vivo related procedures is preferred.
  • Exp managing vendors or an outsourced arrangement is preferred
  • Demonstrated organizational and multi-tasking skills and effective time/program management

 

Competencies:

 

  • Strong communication skills.
  • Experience in working cross-functionally across multiple research areas
  • Strong attention to detail, with the ability to critically evaluate study-related documentation and correspondence

 

 

 

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Nearest Major Market: Philadelphia