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-oriented and timeline-driven. Working with the Program Management Office to ensure cross functional timelines are clear.
• Exceptional written and oral communication skills. Able to explain difficult concepts and influence others.
• Proven ability to keep abreast of technological platform advancements and assess their value to the product success and company’s endeavors.
• Excellent problem-solving skills; demonstrated strength intact and diplomacy working with external and internal collaborators.
• Flexibility and open-mindedness in the face of shifting resources & priorities.
• Willingness to speak up for their interpretations of data or strategy, to ask questions, or to advocate.
• Experience and comfort working effectively within both a direct and dotted-line management structure.

Requirements:

• Education: Ph.D. in biology, molecular biology, genetics or a related field. Domain expertise in cancer is desirable. Minimum of 10 years post-Ph.D. relevant work experience, with > 8 years of industry experience in product development, and at least 5 years of direct management experience supervising scientists at all levels.
• Extensive experience in NGS-based LDT diagnostic product development, with applied knowledge of all CAP/CLIA/NYS, and CLSI guidelines.
• Strong experience in leading cross-functional technical teams in enabling product launch under tight timelines
• Experience writing and coordinating development documentation in a cross-functional capacity, including development plans and reports.
• Excellent written and verbal communication and presentation skills are required.

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