VP of R&D
Our client, privately held, well funded and poised for rapid growth, develops and manufactures nucleic acid-based systems for clinical diagnostic markets. Their patented microfluidic systems are capable of integrating and automating multiple laboratory processes on a single chip. Designed to automate complex sample preparation and for miniaturized PCR, the system is simple to use, allowing minimally-trained personnel to carry out sensitive clinical tests in virtually any environment in less than an hour. The company is well funded and developing disposable test cartridges and corresponding analyzers for nucleic acid-based infectious disease testing and has chosen Group B Strep (GBS), Chlamydia & Gonorrhea (C/G) for its first tests. The company plans to launch GBS late this year followed by C/G and believes their platform will support the relatively easy design and launch of additional new tests.
As a member of the senior management team, the VP of R&D reports directly to the CEO.
Responsible for directing all R&D efforts with three direct reports including two scientific founders.
PhD or other doctorate in sciences or engineering discipline.
A passionate, highly credible, high impact individual with impeccable integrity is essential for success. Candidates must possess strong leadership, motivational, organizational, communication and presentation skills. The successful candidate will be an independent minded, analytical thinker, with a rational and logical decision making style capable of persuading and building consensus. The ability to effect and implement change in the present while developing and building for the future is critical. The successful candidate will have an affinity for technology both as a user and for product applications. They must have a strong desire to grow themselves and an organization. The individual selected will be expected to be an outstanding leader capable of commanding respect and inspiring excellence.
Candidates should posses the following abilities and attributes:
- 10plus years of increasing responsibility successfully developing IVD products, extensive project management experience, a broad based understanding of science and technology and a comprehensive understanding of all the components of IVD Instrument Systems including hardware/software, and reagents.
- Direct “hands-on experience with all aspects of R&D, including project planning, project budgeting, project leadership and development and control of records.
- Strong organizational, process development and managerial skills, as well as an exemplary track record of completing multiple projects on time and on budget.
- Recent track record of successful development and introduction of regulated IVD products.
- Must have a demonstrated ability to innovate and direct the rapid development of proprietary products in a variety of molecular diagnostics related fields.
- Experience with DNA amplification, genomics and detection technologies, plastic cartridge and/or microfluidics technology is desirable, as is experience with lyophilization of chemical formulations.
- Experience with and understanding of FDA processes for 510(k) and PMA as well as CMS reimbursement policies and process as well as CDC and CLIA regulations and process.
- The preferred candidate will have experience in varying business environments and must be comfortable in an entrepreneurial environment where resources come from incremental growth.
The VP of R&D will be responsible for:
The company is seeking an experience IVD Product Development executive with the capacity to accelerate product development programs and enhance their multidisciplinary team of world-class scientists and engineers. This individual will lead the development of nucleic acid-based assays and corresponding disposable test cartridges and analyzers in a regulated environment, collaborating with manufacturing, marketing, regulatory, and quality assurance for rapid, efficient, commercialization of products. The chosen candidate will be expected to achieve results through effective utilization of their technical expertise and leadership and problem solving skills. Responsibilities will include:
- Provide the vision, direction, guidance and motivation to a team of scientists and engineers to ensure they plan and complete multiple projects on time and budget.
- Devise the strategies and systems to optimize the R&D process with a view to manufacturability and robust product performance and to simultaneously track the progress of multiple projects.
- Establish procedures for product design, development and testing.
- Identify critical R&D issues, evaluate and approve all final product designs and design changes, and ensure product specifications are met prior to release into manufacturing.
- In partnership with manufacturing, provide and maintain up-to-date bill of materials (BOM), drawings and other documentation necessary for device history files.
- Provide technical expertise and experimental capability for support of manufacturing, quality assurance, regulatory, and customer support.
- Ensure that all product development processes and activities comply with regulatory standards.
- Ensure seamless coordination of all product development activities, and with other functional areas of the company for rapid product introductions.
DESIRED QUALITIES & DELIVERABLES
The company is seeking an IVD R&D executive with the technical expertise, marketplace knowledge, and passion to establish their presence in the market, and the command to accelerate their product development efforts and lead them to a position of market dominance.
- The ideal candidate will be a well- organized, creative, strategic thinker equally capable of tactical execution and driving results, as well as articulating unique ideas and perspectives.
- The successful candidate will have the presence and integrity to command respect and the confidence and energy to be an effective change agent. They will have an appreciation of and sensitivity to bridging scientific research with marketplace realities and the knowledge and facility to establish business relationships that will optimize the company’s commercialization opportunities.
- The company is seeking an individual who can develop R&D plans that emphasize business planning, acceleration of development cycles & optimization of product development, as well as implement the mechanism, processes, metrics and reporting structure that will drive future growth.
- Candidate must be able to identify business and market opportunities and be capable of preparing new product introductions and of managing and leveraging broader product offerings.
The complete package will include a competitive base salary, highly attractive equity, benefits program, and relocation.
Mr. Larry Glines
39 South LaSalle Street, Suite 714
Chicago, IL 60603