Associate 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:

We are looking for a talented Associate Director to lead a team of scientists and research associates in developing innovative NGS-based molecular diagnostics.

In this role, you will be responsible for product development, leading an assay development team, and collaborating closely with cross-functional partners in support of technical transfer to our CLIA labs and regulatory submissions. This is a high-impact role in which the successful candidate will see the fruits of their efforts implemented rapidly in clinical practice.

Responsibilities:

• Lead product development projects collaboratively and deliver results in a timely fashion in partnership with colleagues across company disciplines.
• Establish goals and timelines in support of company objectives in serving patients. Lead others in a fast-moving environment where product timeliness is essential to commercial success.
• Interact seamlessly with multi-disciplinary teams such as automation, laboratory infrastructure (e.g. LIMS), clinical, bioinformatics / data analysis, regulatory and marketing groups.
• Lead assay development efforts to plan laboratory experiments and studies, including design, optimization, guard band testing, and validation and design transfer to a CLIA laboratory, taking operational implementation into consideration, including automation, QC and LIMS.
• Coach scientific staff and contribute collaboratively on the laboratory troubleshooting needs within and outside of R&D.
• Partner with Bioinformatics/Data Analysis Team to interpret data arising from development studies.
• Transfer developed assays from R&D into production, including training and teaching of CLIA.
• Other duties as assigned.

Who You Are:

• Minimum 8 years of postgraduate laboratory bench experience, with > 5 years of industry experience in product development and > 2 years in team leadership position.
• Prior experience with design controls and phase-gate processes in product development.
• Prior experience developing NGS tests in a regulated environment (i.e., CAP, CLIA, NYS, ISO 15189, ISO13485).
• Sound knowledge in verification & validation activities.
• Prior experience leading cross-functional teams in the design & development of automated NGS-based molecular diagnostic products for high-throughput laboratories.
• A strong track record of delivering results and meeting deadlines in a fast-paced, dynamic environment.
• Ability to use multiple kinds of data to drive decisions.
• Direct experience analyzing and interpreting NGS data.
• A strong track record of developing scientific professionals and providing guidance.
• Experience in regulatory affairs, clinical trials, and intellectual property protection (preferred).
• Significant contribution to the successful clearance of an FDA or IVDR regulated medical device (preferred).

Education:

• A Ph.D.in molecular biology, biochemistry, or a related field.

Other skills and attributes:

• Theoretical and hands-on knowledge of the basic biological principles governing molecular biology, genetics, and biochemistry underlying laboratory assays and clinically relevant information. Knowledge of cancer biology (preferred).
• A strong sense of urgency, independent, goal-oriented, and timeline-driven.
• 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 regarding the company’s endeavors.
• Demonstrate tact and diplomacy when working with external and internal collaborators.
• Flexibility and open-mindedness in the face of shifting resources and priorities.

 

 

 

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The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their