SUMMARY:

• Entrepreneurial senior level life science and healthcare business development and consulting practice leader with extensive new product commercialization, clinical trials, regulatory affairs / pharmacovigilance and market research experience in the pharmaceutical, medical device / diagnostics, and medical technology industries
• Utilized extensive business development skills, contacts and deep knowledge of the life science and healthcare industry to drive revenue growth at two major and one medium sized information technology services companies.
• Expanded business offerings to remain at the forefront of new advances in clinical research and regulatory affairs.
• Worked with C / SVP leadership at top pharmaceutical, CRO’s and medical device companies to develop solutions that fully integrated clinical trial processes, captured clinical data for informatics / analytics, improved commercial operations and enhanced the performance of pharmacovigilance / drug safety systems
• Developed a clinical and commercial patient operations management system to support commercialization of a major international pharmaceutical company’s breakthrough T - cell oncology treatment utilizing patient genomic profiling
• Built a successful life science and healthcare management consulting practice.
• Performed 100+ projects for the top 5 US Management consulting firms, Confidential Analysts, Biotechs, Pharmaceutical and Medical Device Companies.
• Provided expert witness consulting services to multiple organizations in-regards to high profile lawsuits. Modeled, analyzed and worked to resolve complex disputes / issues in the areas of new product commercialization, alliances, regulatory affairs / patient safety, market access, commercial operations and clinical product development.

PROFESSIONAL EXPERIENCE:

Principal Healthcare & Life Science Consultant

Confidential, NJ

Responsibilities:

• Conducted marketplace access and new product opportunity assessments for several Confidential seeking to enter the U.S. marketplace and commercialize new pain and bone growth treatment technologies / therapeutics.
• Provided new product commercialization, market access studies and marketing support services to several international pharmaceutical and medical device companies in the areas of oncology, diabetes, pain and GI
• Clinical projects included: optimizing clinical trial design, evaluation of target drug development profiles, evaluation of prescribing trends / physician and patient behavior, drug safety risk management and epidemiological disease modeling.
• Commercial projects included: pipeline optimization, product and market forecasts, competitive assessment, marketing program evaluation, reimbursement strategy and M & A analysis.
• Retained by a leading international pharmaceutical company to validate the clinical drug development target profiles of four infectious disease compounds.
• Supported analysis by conducting a KOL primary market research study.
• Provided a wide range of expert witness services to several biotechs and major pharmaceutical companies to model, analyze, develop solutions and resolve complex marketplace commercial and clinical trial development related issues

VP Life Sciences

Confidential, Burlington, MA

Responsibilities:

• Joined with the mission of expanding Collaborative’s Consulting practice from primarily area to include the greater NYC pharma belt.
• Worked fulltime on business development and practice expansion projects.
• Built a go-to-market service, “BioIgnition” to enhance new product commercialization and support market access.

Executive Director Healthcare & Life Science Programs

Confidential, Bedminster, NJ

Responsibilities:

• Senior leader in HCL’s Healthcare & Life Science consulting and solutions practice.
• Led the expansion of the R & D business practice at HCL’s top life science accounts.
• Member of a four person team that achieved 125% of performance target $ 65 million (credited portion) out of actual sales
• Conducted multiple consulting projects for C / VP client leadership which enabled HCL to land major project proposals and win deals in the areas of clinical R & D, market access, commercial operations systems and strategies.
• Conducted a long-term consulting project supporting the entire senior leadership team of a top 5 CRO.
• Projects improved clinical trial and laboratory information management systems.
• Audited and improved drug safety / regulatory affairs policies. Developed and implemented a strategic plan to expand the informatics and analytics business.
• Provided ongoing one-on-one consultations with the CEO and CIO to discuss overall corporate strategy.
• Key member of the corporate partnership with Salesforce.com. Other projects included a non-Oracle clinical trial info management platform, electronic health records systems, integrating commercial operations data flows, drug safety / regulatory affairs, real-world evidence healthcare data systems / analytics and M & A assessments.

VP / Practice Leader

Confidential, NJ

Responsibilities:

• Led 7 AVP / Director level consultants and their staff.
• Merged assets and set new business strategy / direction following the Patni acquisition. Used network of industry contacts to expand the customer base which led to a doubling of the prior year’s consulting and solutions revenue.
• Led co-development team and launched Oracle’s Life Science Hub (LSH) platform to support clinical trial integration
• Worked as the Senior Client Partner at strategic accounts to build / grow existing relationships.
• Led delivery and provided hands-on consulting services for projects to improve clinical R & D efficiency, new product commercialization / optimization, market access studies, CRM programs, drug safety / pharmacovigilance systems, alliance management, transmission / storage of patient healthcare data and images and salesforce optimization.

Senior Director, Sales and Marketing

Confidential, Montvale, NJ

Responsibilities:

• Built / led the first commercial operations activities for this biotech company with diabetes, cardiovascular and topical pain / inflammation products.
• Reported directly to the President / CEO.
• In 12 weeks built the sales, marketing and operations commercial infrastructure and launched Confidential ’s first product, a genetic test for cardiovascular risk in people with diabetes

Director Strategic Marketing & New Product Planning

Confidential, Bridgewater, NJ

Responsibilities:

• Developed the corporate sales and marketing strategy and conducted market access studies to support the launch of pipeline products.
• Developed a salesforce expansion plan to support new product launches using a combination of internal assets and external contract sales organizations (CSO’s). Developed materials and trained the new salespersons.
• Primary member of the corporate business development team.
• Managed the international co-development and co-marketing alliance with Confidential .
• Led the corporate new product planning function.
• Managed six pipeline programs for pain, abuse deterrent and metabolic compounds in Phase 2 and Phase 3 development

Marketing Director

Confidential, Paramus, NJ

Responsibilities:

• Restored profitability to the generic product line through elimination of unprofitable products (adjusted production quantities and brought pricing in-line with production costs).
• Sales finished at record levels.
• Primary US representative to Corporate Global Product Development and Marketing Teams
• Confidential was acquired by Confidential Pharmaceuticals and ceased operations

Director Diabetes Marketing

Confidential, Franklin Lakes, NJ

Responsibilities:

• Developed and launched two new blood glucose testing products in 2002
• Led the Confidential professional field sales force restructuring, expansion and project.
• Developed target lists for all managed care accounts and HCP’s to support new product launches and future business growth.
• Aggressively led contracting / market access to achieve 80+ % mkt share in core injectable and diagnostic products
• Key member of several co-marketing and co-development teams.

Confidential, Nutley, NJ

Brand Director

Responsibilities:

• Directed a team comprised of three Product Directors, two Medical Directors, three Product Managers, two Market Research Analysts, three Administrative Assistants and two Leadership Development Program managers.
• Restructured, changed the compensation plan and retrained sales force of 2,000 reps to improve performance and burn-off $ 90 million dollars in excess inventory which enabled us to meet our sales goals in 2000.
• Primary US rep on Roche International’s Infectious Disease Global Business and Clinical Development team
• Directed six Phase 2 - 3 arthritis, respiratory and bone disease new product planning programs
• Conducted a detailed business analysis that convinced senior management that the primary market opportunity for Boniva® lay with a once monthly oral formulation verses its original IV formulation. This led to major revisions in the clinical trial development program which resulted in a blockbuster product.
• Primary US representative on Roche International’s Inflammatory and Bone disease Global Business and Clinical Product Development teams
• Managed three New Product Planning Managers and two Market Research Analysts