Director, Molecular Oncology (R&D)

Reporting to the Executive Director Molecular Oncology R&D, the Director, Molecular Oncology R&D has accountability for directing the MGO MolOnc R&D organization at the Lewisville, TX location in its execution and delivery of IVD product development as well as development of lab developed tests (LDTs) within current quality and regulatory guidelines. Duties may also include technology assessment projects related oncology testing for solid tumors, liquid biopsy, and hematological cancers. The Director will lead a group of R&D scientists to focus on highest priority projects in coordination with franchise partners and the other esoteric oncology sites with input from members of the senior leadership team. The Director will manage internal communications and messages, and own (or identify owners) R&D projects involving oncology to ensure overall efficient processes and execution. They must have strong scientific and product development knowledge, especially in the fields of Molecular Oncology and liquid biopsy test development, including IVD test development; be proactive, have strong leadership skills, and the ability to balance multiple large complex projects.

• Drives development and implementation of the MGO MolOnc R&D plan in LEWS, and serves as the primary R&D liaison from LEWS with Oncology Franchise, key acquisition(s) during integration phase and Pharma Services Franchise in planning and analysis of the technology and products roadmaps for future MolOnc products and services to be developed in LEWS.
• As necessary, recruits and trains, organizes a high performing team of R&D scientists knowledgeable in the development of plans (budget, resources and timelines) and execution of said plans in a design control regulatory environment.
• Drives the development/implementation of technologies and processes required for MGO R&D to operate at a high level of efficiency, discipline and speed in the assessment of MolOnc opportunities (e.g. early detection cancer screening and CDx pharma services) under consideration for partnering by the Oncology Franchise.
• Serves as a SME on design control based product development for both US and EU. Participates on Development Core Team Meetings as assigned.
• Using QMS tools, has oversight of LEWS projects by establishing a reliable, sustainable operating rhythm to the support the leadership team and support teams.
• Sets pace for meeting key timelines, manages expectations and ensures transparency of project priorities and status through a regular cadence of monthly project reviews.

Required Work Experience:

6 years or more of experience in senior R&D positions focused on the development of NGS-based Liquid Biopsy Molecular Oncology assays In the diagnostics industry (both RUO and IVD).

Eduation:

PhD Required

Post-Doctoral Research a plus

Physical and Mental Requirements:

Normal for a role based in the Lewisville laboratories. Some limited travel possible to other Quest sites and internationally for meetings.

Knowledge:

• Knowledge and understanding of the trends and forces shaping the health care delivery system, the provision of care, and other emerging issues in healthcare management.
• Extensive knowledge of the technologies, bioinformatics, automation and chemistries associated with the development of NGS-based Liquid Biopsy assays for MolOnc
• Skilled in leading high performing product development teams
• Good interpersonal and communication skills, as demonstrated via a track record of scientific conferences talks/posters/abstracts and publications in peer review journals
• Highly developed ability to work effectively with a variety of constituencies, and ability to lead and manage through influence and delegation.
• Demonstrated capabilities in cross-functional process assessment, problem- solving and process improvement.

Skills:

• Molecular Biology product development skills including development of life sciences products for the in vitro diagnostic (IVD) space.
• Skill and experience developing with design control principles.
• Management of junior level scientists.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets