COMPANY
Our client is an innovative early stage biotechnology company utilizing PCR based Mass Spectrometry technology to commercialize renal and cancer IVD products. The clinical performances of The Company’s assays are far superior to existing molecular tests because they yield results which have both greater sensitivity and specificity. The Company has developed molecular diagnostic tests that have the means to significantly improve the manner by which cervical cancer and its precursor lesions are identified and monitored. Their assay technology is also able to identify each viral subtype with which the patient is infected. The Company has other commercialization opportunities with their unique gene-based molecular tests already in development.

ENVIRONMENT
Early stage development company privately held and offers an open, collegial, entrepreneurial working environment and provides opportunity for significant contribution and impact.

POSITION DESCRIPTION
The Vice President of Product Development will be a significant force in the building of the company and a key driver in the commercialization and delivery of unique gene-based molecular tests. The successful candidate will collaborate with the senior management team to develop molecular diagnostics based on The Company’s proprietary PCR based Mass Spectrometry technology that will enhance the clinician’s ability to detect and monitor disease states. The individual selected will help articulate the vision and devise the means to achieve specific development milestones. They will have direct and indirect supervisor responsibility for multiple development projects and function as technical spokesperson and scientific ambassador. They must be aware of the technology and operational challenges that can affect successful outcomes and ensure the smooth and successful development, transfer and marketing of new products.

REPORTING
The VP of Product Development reports directly to the CEO.

REPORTING RELATIONSHIP
Responsible for leading all intramural and extramural product development efforts which will include hiring staff and working without outside collaborators.

EDUCATION
PhD or other doctorate in sciences or engineering discipline.

PERSONAL CHARACTERISTICS
A knowledgeable, highly credible individual with impeccable integrity is essential for success. Candidates must possess strong analytical, leadership, motivational, organizational, communication and presentation skills. The successful candidate will be an independent minded, pragmatic 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 science & technology both as a user and for product applications. They must have a strong desire to grow themselves and an organization and have the capacity to command respect and inspiring excellence.

RESPONSIBILITIES
Candidates should possess the following abilities, attributes and experience:

The VP of Product Development will:

• Interact effectively and collaborate with the senior management team to assure the realization of the company’s goals of providing superior diagnostics that enhance the ability to monitor progress of disease states and improve human healthcare.
• Collaborate with the CSO and research team to transfer knowledge and technology from one functional area to another and identify the gaps that require additional development focus to ensure or improve product performance.
• Provide the vision, direction, guidance and motivation to a team of scientists to ensure they plan and complete multiple projects on time and budget. Provide project updates to senior management on a routine basis.
• 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 and maintained external research sites for clinical trials and validation of new products.
• Establish procedures for product design, development and testing that facilitate the integration of leading edge development tools and methods that result in advancing prototypes through all phases of development and optimize product transfer into routine manufacturing.
• 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.
• Develop the processes and documentation systems to ensure that all product development processes and activities comply with the FDA’s QSR Design Control requirements. Oversee compliance with GMP, safety, and regulatory requirements for pilot scale production, lab lots, transfer to manufacturing and introduction of ASRs.
• Provide technical expertise and experimental capability for support of manufacturing, quality assurance, regulatory, and customer support.
• Establish and maintained contacts with industry and academic leaders to achieve company business goals and development strategies.
• Establish and maintain contacts with industry and academic leaders to achieve company business goals and development strategies.

REQUIREMENTS
Candidates should posses the following experience, abilities and attributes:

Areas of Expertise

• Product development management
• Clinical trial design and management
• IVD instrument and reagent manufacturing systems, including Lean Manufacturing
• FDA Quality System Regulations
• Facility planning and management
• 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.
• Experience with and understanding of ASR’s, the 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.

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.

COMPENSATION
The complete package will include a competitive base salary, highly attractive equity, benefits program, and relocation.

CONTACT
Glines Associates
Mr. Larry Glines
39 South LaSalle Street, Suite 714
Chicago, IL 60603
312.580.0646
search@glinesassociates.com
www.glinesassociates.com