FULL CYCLE PRODUCT/ASSAY DEVELOPMENT for INFECTIOUS DISEASES = STRONGLY PREFERRED
The Senior Director, Research & Development will be responsible for executing the technology vision, shaping technical strategy, and driving development and execution for the business. This person will recruit world-class talent, manage the appropriate development methodologies, and create the proper organizational structure to drive a high performing development team to deliver solutions to the market with relentless execution. This person will keep abreast of and influence technology trends, standards, while working in tandem with the other members of the Business Unit leadership team. This person will work closely with business development and the product marketing team to further define our product roadmap and deliver against it. This person will have the ability to bridge technology with business acumen, will bring experience in developing industry leading products, and will develop and sustain a culture of passion, hard-work and innovation. Position reports to the Senior Vice-President/General Manager of the Business Unit and will oversee a North America (US & Canada) team.
May perform some or all of the following:
- Develop, direct and maintain a system to manage all product development programs and projects, including a rigorous review process, in order to ensure attainment of key milestones and adherence to product specifications, timelines and budgets.
- Lead the R&D and clinical teams to promote a high-performance, results-driven environment with a strict adherence to project management requirements.
- Support Marketing in developing a strong product pipeline and a portfolio of marketed products that are differentiated and provide competitive advantage for the company.
- Formulate and implement the long-term strategy with respect to new and emerging technologies that advance company objectives.
- Attract, develop and retain top talent for the R&D and Clinical Affairs functions, while motivating staff to continually improve its performance.
- Support the identification, monitoring and, in conjunction with business development, the licensing/acquisition of new technologies that can be incorporated into the company’s current and future products.
- Work with Quality and Regulatory to ensure products are developed and validated in a manner that complies with global regulatory requirements.
- Directly responsible for the establishing and managing the operating budget.
- Ensure that the research and development organization provides technical assistance to other departments.
Education and Skill Requirements:
- Bachelors degree in engineering, chemistry, biotechnology or related sciences required. Masters degree preferred and PhD is a competitive advantage.
- Minimum of 12 years of experience in progressive research and product development leadership roles with a minimum of 5 years experience at the senior leadership level in global companies that develop, manufacture and sell complex medical devices and diagnostics products. FULL CYCLE PRODUCT/ASSAY DEVELOPMENT for INFECTIOUS DISEASES = STRONGLY PREFERRED.
- Integrated project management skills are required.
- Experience in setting and scaling the research and development function, with the proven ability to attract, inspire, motivate and retain top tier talent.
- Proven ability to establish, articulate and implement a concrete product development strategy that clearly aligns with corporate and commercial goals.
- Medical Device Regulatory, Quality Assurance and Compliance experience.
- Detailed understanding of the in vitro diagnostics landscape, to include the competitive landscape and technologies.
- Experience with distributed teams and business partners.