Senior Director, Product Development

At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte – whether it be in one of our labs, corporate offices, the field – enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a results-driven environment that values innovation, collaboration, and compassion.

The Position:

Location: This is an onsite position based in our South San Francisco location. 

About the Role: We are seeking an exceptionally talented and strategic Senior Director, Product Development to lead and drive the evolution of our regulated diagnostic product portfolio. This is a critical leadership position responsible for spearheading the end-to-end development and successful launch of cutting-edge diagnostic tests, leveraging our high-throughput diagnostic platform. The ideal candidate will possess deep expertise in enabling high-throughput assay development within a regulated environment and will champion a forward-thinking approach to accelerate product timelines by building scalable, reusable solutions. This role will significantly contribute to our company's success by delivering innovative, high-quality diagnostic solutions while ensuring strict adherence to design control and regulatory requirements.

Key Responsibilities:

1. Strategic Product Leadership:
   • Have good bioinformatics knowledge on molecular (especially NGS) data to enable data interpretation and appropriate study design.
   • Define, own, and drive the product development strategy, ensuring alignment with the company's overarching diagnostic platform vision and market needs.
   • The candidate will ensure that all activities related to the given project are executed according to established requirements for the products and ensure quality-control metrics that will be validated for operational excellence.
   • Working within regulated environments, especially with CLIA/CAP and NYSDOH regulations. The successful candidate will apply their expertise in NGS-based assays to oversee the development of robust assay workflow that will be validated and productionize.
   • Instill a pervasive culture of quality, scientific rigor, proactive risk management, and continuous process improvement throughout all phases of product development.
2. Cross-Functional Collaboration & Stakeholder Engagement:
   • Interact seamlessly with multi-disciplinary teams such as automation, laboratory infrastructure (e.g. LIMS), clinical, bioinformatics / data analysis, regulatory and marketing groups. Fostering cross-functional synergy in a fast-moving environment where product timeliness is essential to commercial success.
   • Act as a key strategic partner and influential bridge across R&D, Clinical Affairs, Regulatory Affairs, Operations, and Commercial teams to ensure seamless alignment, effective communication, and successful product realization.
3. Integrated Team Leadership & Development:
   • Within the assay team, the candidate will guide the team to develop fully interpretable and actionable experimental designs suitable for high-throughput laboratory operation, ensure robustness and efficiency throughout the process of the product life cycle.
   • Lead a team of scientists at various level, provide direct mentorship, coaching, and performance management to team members, supporting their professional growth and career trajectories within the organization.
   • Responsible to ensure the transfer of developed assays from R&D into production, including coordinating training and design transfer to CLIA laboratory operators.

Who You Are:

• Proven success leading projects collaboratively cross-functionally with delivery of results in a timely fashion and partnering with colleagues and across company disciplines.
• Theoretical and hands-on knowledge of the basic biological principles governing molecular biology, genetics, and biochemistry underlying laboratory assays and clinically relevant information. Demonstrated ability to tie the results of the team’s analysis back to specific assay and product need.
• Establish goals and timeline in support of company objectives in serving patients. Demonstrated ability to thrive in a fast-moving environment and acknowledge that product timeliness is essential to commercial success.
• Familiarity with design controls and phase-gate processes in product development, translating that into the insight for experimental design through prioritizing must have over nice to have.
• A strong sense of urgency, independent, goal-o