Associate 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 Associate 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 functions to provide input to manufacturing, quality, regulatory, and commercial assessments). Establishes criteria for go/no go working with appropriate SMEs. Benchmark Spark's CDx needs against potential partners, recommend partners for specific programs, and define deliverables and budgets for contracts with partners.

5% of time- 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.

5% of time- Represent the Spark CDx Team to external stakeholders (e.g. health authorities, presentations at scientific meetings etc).

5% of time- May participate in interactions with regulatory authorities, commercial planning efforts, and medical strategy related to the diagnostic product.

REQUIREMENTS

• MS or PhD in a Life Science with a minimum of five years of industry experience in Companion Diagnostics development, validation, global registration, and commercialization including deep and broad experience with use of investigational assays for patient selection in global clinical trials. Candidates with a BS and exceptional industry experience will also be considered.

• Demonstrated track record of successfully managing Companion Diagnostic development projects from beginning to end.

• Possess basic project management skills to inform project timeline development, program risk assessment and mitigation, and ensure effective communication during project execution.

• Demonstrated working knowledge of design controls, analytical, clinical, and manufacturing process validation requirements for IVDs, GCP, GLP, and GMP requirements; working knowledge of requirements for US and global regulatory submissions related to IVDs for use in clinical trials and for commercialization of companion diagnostics.

• Familiarity with gene therapy or rare disease therapeutics development process including patient selection for clinical trials. Knowledge and understanding of established and novel assay technologies utilized with gene therapies or therapies for rare diseases.

• Demonstrated success collaborating with business units required during end-to-end CDx development (including but not limited to business development, finance, legal, alliance management, program management, research, development, regulatory, commercial, marketing, medical affairs, and quality) to achieve goals.

KEY SKILLS, ABILITIES and COMPETENCIES

• Strong motivation to drive towards achieving project and program goals with limited supervision.

• Demonstrated ability to lead cross-functional teams to achieve goals.

• Ability to consistently anticipate next steps for CDx projects and proactively take actions to create momentum within a CDx development program.

• Ability to establish relationships across disciplines both internally and with CDx partners.

• Ability to work effectively as a member of multidisciplinary therapeutic development matrix teams and influence within cross-functional team where appropriate. Serve as CDx representative on Spark Development teams.

• Superb communication skills, both oral and written, are required. Ability to communicate and collaborate actively across organizations and functions internally and with multiple disciplines within external CDx partners.

• Capability to contribute information and ideas to decision-making process for the completion of team goals.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.