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Safety Assessment and Study Operations Lead

Date: Jun 10, 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.

 

Primary Duties:

 

The Safety Assessment and Outsourcing Lead will be responsible for coordinating the implementation of nonclinical safety and toxicology studies and associated activities by interfacing with internal stakeholders and external collaborators such as Contract Research Organizations (CROs) to offer assistance when needed with initial study designs, obtain project estimates, assist with the development of study protocols, assist Study Monitors with the logistical components of all nonclinical and toxicology 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 and toxicology studies, and ensure alignment with internal development team timelines
  • Serve as the point of contact for implementation and monitoring of non clinical toxicology studies.
  • Ensure that the preclinical safety plan for the program is aligned with the clinical development plan, applicable regulatory guidelines (FDA, GLP), and program objectives
  • 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
  • Collaborate with Research colleagues in the further development of clinical assets and IND candidates, etas well as novel assets to support the pipeline
  • Act as primary contact for Spark to ensure consistent practices across vendors, groups, and sites.
  • Lead the effort to develop document management and review systems for outsourced studies.
  • Track and forecast activities and budgets to ensure Company priorities are met.
  • Work cross-functionally across the organization to ensure effective execution on nonclinical program deliverables, including with Research, CMC, Regulatory, Clinical functions,Quality assurance, and Quality Control teams
  • 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

% of Time           

                         Job Function and Description

50 

  • Coordinate and oversee all animal procurement and screening for external nonclinical and toxicology  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

 

Education and Experience Requirements:

 

  • B.S/M.S/PhD in Biology or related field required
  • Generally has at least  6 to 8 years (for M.S.) or 4 to 6 years (For Ph.D.) 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

 

Key Skills, Abilities, and 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

 

Complexity and Problem Solving:

 

  • Considered an internal SME on in vivo experiments within Spark
  • Develops solutions to complex problems which require the regular use of ingenuity and innovation.
  • Ensures solutions are consistent with organization objectives

 

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Nearest Major Market: Philadelphia