Position Details

Position Title: Chief Scientific Officer
Location: Atlanta, GA
Position #: 3028

Scope of Responsibility

The Chief Scientific Officer will have overall worldwide responsibility for all aspects of Research & Development and Technology Assessment functions (inclusive of development and improvement) as well as being a member of the Leadership team.  The Chief Scientific Officer will have frequent interactions with the Executive Leadership team, Area GM’s, other members within organization, key associations as well as foster relationships with key opinion leaders and institutions around the world.

• Serve as part of the senior executive team that directs the Company and develops strategy, especially regarding the desirability and feasibility of pursuing new product opportunities.
• Act as chief architect of strategies and programs to bring new products to the point where they can be handed off to production (in a form which will comply with regulatory mandates), and improve the quality of existing products.
• Expand and direct the implementation of the Company’s IP strategy, and maintain and strengthen the Company’s portfolio of intellectual property, including Patents and Trademarks, and manage the activities of patent counsel.
• Establish appropriate objectives and budgets for all development functions consistent with the Company’s overall business plan and annual operating plan/budget.  Ensure the appropriate internal and external resources are in place to accomplish the objectives and manage them to results.
• Maintain responsibility for production and/or acquisition of all developmental prototypes.  Make make/buy decisions with regard to in-house versus out-sourced development activities and put in place the resources, methods and systems to ensure objectives are met.
• Work with the VP of WW Operations -- the CSO will have input regarding not only how to refine and improve production processes to improve cost and quality, but also to extend the value and proprietary nature of the Company’s intellectual property.
• With the R & D departments reporting to the CSO; ensure ongoing compliance with FDA, ISO and other regulatory & quality standards.
• Work in concert with RA/QA to oversee the conducting of initial clinical trials required to support FDA and other regulatory submissions, as well as the preparation and submission of such applications as needed.
• Implement an effective, but lean, internal organization that is highly committed and dedicated to the Company’s success.  Employee job satisfaction and employee opportunity are important credos to be instilled.

 

Qualifications

• Mandatory PhD in Chemistry, Biochemistry, Molecular Biology or Serology.  B.S. in business or life sciences strongly preferred.  MBA a plus.

• Mandatory 15+ years of development-related experience with regulated in-vitro clinical lab diagnostics inclusive of instrumentation, reagents and middleware/IT, including at least 5 years as senior executive in charge of overall development programs (Divisional or Business Unit Lead) in an in-vitro clinical lab diagnostics company.

• Mandatory Business Acumen and Leadership responsibilities outside of R & D linear career path.  Critical nature of position requires scientific & technical capabilities with business leadership that results in competitive advantage and sustainable commercial success.

• Mandatory in-vitro diagnostics P & L experience with strong preference for Hematology, Flow Cytometry, Molecular/Amplified Technologies, Immunology and/or Serology.

• Mandatory R & D and business redesign or restructuring experience and demonstrated performance.

• Demonstrable track record of bringing new diagnostic instruments, reagents and middleware/IT devices from product development through successful market launches, including post-launch product improvements.

• Mandatory experience and proven performance in building ‘best in class’ R & D corps, loyalty organizations in the IVD industry; Desire large and entrepreneurial experience and performance excellence.

• Mandatory Portfolio Planning and Lifecycle Management experience in IVD markets with instrumentation, reagents and middleware/IT.

• Mandatory track record of monitoring and improving R & D productivity; must be able to develop metrics that are clear, specific, attainable and foster teamwork and cooperation to a common set of objectives.

• Documented experience in obtaining patents and managing an IP portfolio.

• Successful track record of compliance with all relevant FDA, ISO, OSHA, EEO, etc. and other international regulations.

• Strong mechanical and process skills.  An understanding of automation, methods improvement, in-process controls, etc. and how to design for manufacturability

• Personable but strong leader who can put together R&D organizations and get the most out of his/her people.  A person who engenders a culture of productivity, esprit d’ and commitment throughout his/her organization

 

 Compensation

• A highly attractive compensation package, including a significant equity position commensurate with the strategic importance of this position, will be fashioned for the successful candidate.  Customize relocation requirements (no home sale purchase).

 Travel

• First 6-18 mo. based in Warren, NJ – Commute to NJ acceptable with Mon – Fri expectations; Corporate apartment furnished at company expense. 

• After objectives successfully completed in NJ, relocation to Atlanta, GA (Mandatory HQ location) - Domestic & international travel is required.

 

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