Bill Lever, Phd, Mba Email & Phone Number

Pittsford, Ny

Bill Lever has extensive executive experience in the areas of medical devices, pharmaceuticals, and consumer products, which is leveraged through The Lever Group focus on assisting small and emerging companies, especially in life sciences and consumer products areas, with strategy development, business planning, general management and product development, particularly in that critical stage between the emergence of the technology and the final development of a successful commercial product.

Independent consultant in strategy and product development, especially for small and emerging health care companies.

Accountable for global product development management processes and key business interfaces to strengthen and improve global product development in all product categories and to facilitate strategic portfolio planning.> Directed enhancements of product development processes and support for major R&D expansion. Strengthened development processes and design control systems for medical devices; implemented a process for pharmaceutical development; trained project leaders and functions in new processes.> Established R&D intellectual property groups as the interface between patent law, project teams and functional areas to ensure unified IP mission and operational logistics across all product areas.> Leadership for directors of Pharmaceutical and Surgical Development Committees to ensure maximum consistency in these governance committees; member Pharmaceutical Leadership Team> Leadership for directors of external technology and technical diligence for all product areas.> Expanded Design for Six Sigma (DFSS) group and broadened DFSS deployment and awareness, and established internal MEMS expertise to manage external MEMS interactions. > Oversight for facilities and space management during rapid R&D expansion, including major (75K sq feet, >$20MM) new R&D facility construction which opened in December 2006.

> Responsible for global product development and marketed product support for all product areas (vision care, surgical, OTC and pharmaceutical). > Nine direct reports / 140 indirect reports in Rochester, NY; Tampa, FL; Münich, Germany, and matrix responsibility for 55 Pharmaceutical Development staff in Europe located in Berlin, Germany and Montpellier, France. > Led evaluation of resource needs, systems and processes to ensure effective global cross-site and cross-functional interfaces and interactions in pharmaceutical development. Demonstrated effective management in both rapid growth and downsizing business environments in response to business needs.> Directed CMC efforts that led to 2005 approval and launch of the NDA products Zylet™ and Retisert™, and directed development of 9 ANDA generic ophthalmics, nasals and inhalants, 3 OTC eye care products, new nutritional Ocuvite and PreserVision formulas, and provided development support for new lens care products, contact lenses and surgical products, e.g. IOLs and inserters.

Added responsibility for program direction for OTC eye care and contact lens care (50% divisional revenue) to existing business development role. Led global project team in the development of ReNu MultiPlus, a contact lens care product that was launched globally and became the largest revenue product for B+L.

Led a group in identification and evaluation of new technologies, products and businesses for strategic growth. Member of B+L diligence teams for 1997 acquisitions of Chiron Vision and Storz Instruments to create the B+L Surgical Division.

Developed global clincal trials capability and outsourcing network to support product registration, claim support and competitive assessments, and provided direction for an in-house Research Clinic to support domestic product development.

Directed product research, registration support and marketed product support for all division product categories, including eye care, OTC monograph products, contact lens care, oral care and skin care, through departments of chemistry, microbiology, cell biology and toxicology, competitive products, clinical and new ventures. Developed new eye, lens, skin and oral care products and achieved the Rx-to-OTC switch of Opcon-A.  Established and managed a Scientific Advisory Board for the division, organized key annual customer focus groups, sales force product training, strategic portfolio planning, restructured processes and functions to align with business strategy.

Cardiovascular discovery research focused on new antihypertensives, renal vasodilators and cardiotonics.

Research Triangle Park, Nc

Medicinal chemistry discovery research in varied therapeutic and chemotherapeutic areas.

Mba, Finance, Marketing, Entrepreneurship

Phd, Organic Chemistry

Activities and Societies: Commission on MIT Education

Ms, Bs, Chemistry

Activities and Societies: American Institute of Chemists Medal and Award, Pi Mu Epsilon