As a member of larger Immunology Team in the Translational Department, the Preclinical Immunology Lead is responsible for strategic planning, execution, and reporting of pre-clinical immunology studies; initiates and directs immunological initiatives to support all Spark therapeutic areas with the goal of increasing safety and efficacy of all therapeutics. Proposes novel strategies to modulate immune responses in the context of gene therapy;. Keeps abreast of scientific and technological innovations. Directs external collaborations with the support of a dedicated business development partner. Leads a group of Scientists and Research Associates to support in-house immunology studies. Oversees CRO management for outsourced preclinical activities; develops novel immune assays in support of the Spark pipeline. Responsible for ensuring that all studies are compliant to relevant SOP guidelines and aligned with regulatory agency expectations.
Job Function and Description
Assume responsibility for strategic planning, execution, and reporting of pre-clinical in vivo and in vitro immunology studies in compliance with the appropriate regulatory guidance documents
Oversee CRO management for outsourced preclinical activities
Develop novel immune assays in support of the Spark pipeline
Directs external collaborations with the support of a dedicated business development partner
Keep abreast of new scientific/technology development by participating in scientific meetings/seminars and through regular scientific review.
Education and Experience Requirements
- Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback. Hold everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by periodically reviewing individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
- Develop team members. Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential. Understand your employee’s goals, strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning, social networks and development opportunities.
- Foster Spark’s Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
Key Skills, Abilities, and Competencies
- Ph.D. in Immunology or related field required and at least 6 years of relevant post degree experience
- Previous experience as a team leader is preferred
- A strong background in immunology and AAV gene therapy is preffered
Complexity and Problem Solving
- A strong background in immunology and AAV gene therapy
- Extensive experience overseeing preclinical study design and execution and in vivo model development
- Expertise in CRO management and oversight for in vivo studies
- Familiarity with the preclinical regulatory requirements for gene therapy programs
- Familiarity with IND enabling studies
- Excellent communication skills with the proven ability to work effectively as a member of a multidisciplinary team
- A strong publication record is a plus
- Experience in managing team is a plus
Internal and External Contacts
- Considered expert in field within the organization
- Develops solutions to complex problems which require the regular use of ingenuity and innovation
- Ensures solutions are consistent with organization objectives
Preclinical Immunology Lead is accountable to the Immunology Leader and serves as a key collaborator and peer to Immunology Team Leads; will be in contact with Regulatory and R&D Operations and Technical Operations. In carrying out this role, the incumbent will partner closely with the leads of different therapeutic areas, a broad range of external experts (e.g. scientific advisory board) in the field of gene therapy.
Other Job Requirements
Minimal travel required, up to 5%
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.
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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 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.