Director, Companion Diagnostics

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 unlock the power of gene therapy to accelerate healthcare transformation. 

 

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

 

 

In this role, the Director Companion Diagnostics will serve as the Companion Diagnostic (CDx) subject matter expert responsible for driving CDx development programs required for patient selection strategies for Spark’s gene therapy development teams, ensuring that the CDx deliverables align with the gene therapy development program milestones at critical junctures.  Anticipate hurdles in the CDx development program and successfully prevent or navigate to minimize impact to gene therapy development programs. Contribute to Spark’s overall strategy for developing CDX capabilities.   Acquire and disseminate knowledge regarding the CDx landscape and state of the art to enhance organizational learning and inform strategic decisions.

 

 

RESPONSIBILITIES

 

60% of time- Responsible for end-to-end execution of the CDx strategy for specific gene therapy programs.  Primary point of contact with CDx partner (day-to-day) to monitor assay development and validation activities, transfer progress, troubleshoot, communicate evolving needs to ensure timely implementation of CDx strategy.  Lead the Spark CDx cross functional subteam(s) and the Dx partner-facing joint CDx Project Teams (with team management support from Program management) covering all areas from CDx assay development through CDx approval and launch.  Lead working groups consisting of internal and partner team members to deliver on CDx strategy.  Serve as a member of or lead subteams for specific deliverables related to companion diagnostics programs.  Be accountable for delivery of diagnostic partner critical milestones, including assay development, analytical validation, clinical validation, and regulatory activities. 

 

15% of time- Serve as primary point of contact and CDx program SME for other functions requiring input from CDx.  Support Regulatory Affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally. Provide CDx-related content for other documents (briefing books, applications, etc) that are provided to regulatory authorities. Advise as CDx SME on regulatory strategies and risk determinations for CDx programs. Participate PMA preparation in partnership with Regulatory Affairs and Dx partner. Advise as CDx SME on any CDx-related Internal Quality systems, External Quality systems and Compliance related topics (eg audits) serving as the CDx technical expert. Provide input into Dx related commercial strategies, (access and product launch).Support of customer facing activities (ad boards, meetings) as the CDx expert.

 

10% of time- Triage Spark’s gene therapy development programs to define CDx development needs and identify potential CDx partners.  Initiate and provide direction for search & evaluation efforts for diagnostic partnering.  Participate in Partnership Diligence and Selection Decisions (Leading technical assessment and including relevant f