Head of Research & Development

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As a member of the Gen Mark Leadership Team, you will be responsible for the strategic direction and leadership of the R&D team. You will oversee the overall design, development and launch of the company's assays, consumables and instruments. You will be responsible for the development strategy for molecular diagnostic assay products on the next generation sample to answer platform utilizing the company's ePlex Detection technology.

You will also have functional responsibility to build and develop core competency in scientific excellence in molecular diagnostics, functional consumables design, manufacturing processes, design control, clinical study and submission support.

You will oversee product development for Genmark including, engineering design and scale-up processes. You will also ensure development processes comply with regulatory requirements to minimize risk to the organization, as well as address the analysis and evaluation of process development procedures and practices to ensure compliance with regulatory, legal and good manufacturing procedures to meet corporate goals. You will report to the General Manager and lead a team of Directors and Managers.

• Directs and manages multiple programs to develop assays and systems for future ePlex products.
• Oversees system-level design and technical review.
• Guide the creation and execution of an integrated program plan to develop and launch new products.
• Guide the creation and execution of an integrated program plan for any product development activities needed for on market product/ PCQT (Product Care Quality Team deliverables).
• Drives cross-functional teams to deliver new products to specifications, on time and on budget.
• Leads a team of Directors and Managers in technology assessments and development for automation of DNA/RNA extraction, PCR and assay integration of assays onto sample to answer platforms.
• Works closely with the Clinical, Regulatory and Quality departments for successful clinical studies, regulatory submissions and design control processes.
• Collaborate with manufacturing and supply chain to facilitate effective transfer of assays to manufacturing.
• Engage, influence, and direct all functions and partners involved in product development.
• Aligns with Marketing and Sales on new product requirements and commercialization activities.
• Accountable for ensuring products meet customer needs and business objectives.
• Guide the team to generate novel ideas for defining, developing and launching new products.
• Manage project and product risks and initiate reviews with oversight committee if necessary.
• Manage project and department budgets and actively make tradeoff calls between schedule, scope and resources to meet overall program and business objectives.
• Reinforce business perspective and enterprise thinking during development process.
• Act as product champion internally and externally.
• Maintains organizational focus and expertise on innovation best practices and scientific excellence.
• Hands‑on leader that can inspirationally motivate a team to meet challenging but achievable program deliverables.
• Provides an open environment and promotes teamwork across the organization.
• Fosters know‑how exchange and collaboration with global R&D teams within the Roche Diagnostics Division. Leverages their expertise in projects to achieve Genmark's business goals.
• Builds and provides leadership for an effective team including hiring, onboarding, developing, goal setting, performance improvement and disciplinary actions.
• Effectively utilizes internal and external resources to meet project objectives.
• Demonstrates and advocates Our Operating Principles.

• M.S. or PhD in Life…