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Principal Scientist - Toxicology

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Aug 26, 2022

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Discipline
Health Sciences, Drug Development, Toxicology
Job Type
Staff Scientist
Organization Type
Pharma
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Job Details

Primary Duties:

The Department of Pharmacology and Toxicology within Developmental Sciencesis seeking an experienced toxicologist to develop and lead the execution of nonclinical safety strategy for gene therapy programs at Spark. The individual will serve on Compound Development Teams for pre-clinical stage programs and on Non-Clinical Study Teams for clinical stage programs across the various therapeutic areas within Spark with a concentration in liver and CNS directed therapies.The successful candidate will use scientific and drug development expertise to play an important role in the development of gene therapies to address the high unmet medical need in rare and ultrarare diseases and rapidly advance early assets though the pipeline.

To this extent the individual will work in a collaborative team environment, to develop and implement the nonclinical safety strategy in assessment of Spark’s gene therapy portfolio. Individual will partner closely with the research team leads as well as other key stakeholders within Spark (regulatory, clinical, CMC, etc.), CROs, and/or external collaborators to design, execute, interpret, and report nonclinical (GLP and non-GLP) studies. Individual will ensure timely and accurate communication of study results and interpretation to appropriate internal teams and governing committees, contribute to discussions and facilitates decision making. Individual will help author necessary global health authority (INDs, CTAs, PIPs, BLAs, etc) and clinical (protocols, IBs, ICFs, etc) documents and represent Spark at necessary global health authority meetings.

Responsibilities

  • As a member of cross functional project teams, collaborate with cross functional team members to develop and drive integrated non-clinical toxicology and pharmacology strategies.
  • Provide scientific leadership in the design and implementation of safety assessment strategies to support program advancement and decision-making, including design and execution of necessary regulatory/GLP/nGLP studies to support program and regulatory milestones.
  • Proactively manage potential safety liabilities and communicate the impact to teams and governance committees. Support the design of necessary investigative studies to identify and mitigate treatment-related toxicities.
  • Preparation and review of study protocols, study reports, manuscripts, etc.
  • Deliver high quality nonclinical summaries and other high-level regulatory documents for internal decision making and for external health authority submission (including but not limited to IND/CTA, HA briefing books, Investigator Brochures, GMO documents, etc.).
  • Represent Spark at global health authority meetings as needed.
  • Maintain current knowledge of gene therapy regulatory guidance, industry standards and recommendations, and stay current on relevant literature and methodologies specific to the non-clinical safety of gene therapy products.
  • Partner with the CMC organization to address any product specific issues that may impact development of a gene therapy candidate.

Education and Experience Requirements

  • A PhD in toxicology or a relevant field along with a minimum of 8 years of relevant experience in the pharmaceutical/biotechnology/CRO industry related to toxicology.
  • Experience in drug development and interaction with global regulatory authorities are preferred.
  • Experience with cross-functional teams and capability to build productive cross-functional collaborations are required.
  • Experience in writing nonclinical sections of regulatory documents and regulatory interactions.
  • Experience in designing non-GLP and GLP toxicology studies in support of pipeline decision making and regulatory milestones.
  • Understanding of CMC, QA, regulatory and clinical stages to guide preclinical activities setting up products for success at later stages.
  • Previous experience with gene therapy drug development or CNS drug development is preferred.
  • The successful candidate must also demonstrate strong decision-making, complex problem solving, critical data analysis and interpretation, excellent written and verbal communication skills.
  • Organized and skilled in managing and prioritizing multiple responsibilities, tasks, and projects.

Other Job Requirements

  • Some business travel required (Main travel will be Health Authority meetings and CRO visits.
  • Other travel could include conferences, off sites, etc)

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.


Nearest Major Market: Philadelphia



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.

Company

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.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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