Associate Director, Product Development

About 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.

Requirements

• 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.

Nice-to-haves

• Experience in regulatory affairs, clinical trials, and intellectual property protection.
• Significant contribution to the successful clearance of an FDA or IVDR regulated medical device.

Benefits

• Competitive compensation and benefits.
• Discretionary bonuses/incentives.
• Restricted stock units.
• Career opportunities in a growing company.
• Inclusive workforce fostering diverse backgrounds.