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Senior Scientist, Pre-Clinical R&D and Business Development Expert Consultant Resume

Resume of RXY, Ph.D. Consultant
Principal Industries Served:
  • Biotechnology
  • Pharmaceuticals
  • Medical Devices

Education:

This expert has a Ph.D. in Molecular Genetics from the University of Massachusetts Medical.

This expert has a B.S. in Animal Sciences from the University of Massachusetts Amherst.

This expert also has Medical Device Management Certification, from Worcester Polytechnical Institute.


Expertise and Services:

Senior Scientist, Pre-Clinical R&D and Business Development Expert Consultant Resume

This associate is an expert in biomedical, pharmaceutical, and medical device industries with extensive expertise in strategic business development. Further expertise includes early product development with advanced knowledge of diabetes and its complications, autoimmunity, metabolic and cardiovascular diseases.

Product, Process Development Expertise

This associate is a senior-level project manager with expertise in the use of stage-gate processes to move novel chemical entities, macrobiologics and with medical device technology from conception to a functional formulation/prototype and validation testing preceding regulatory approval.

Science, Research Expertise

This expert is an innovative senior scientist and research director with significant experience applying stage-gate principles to drive development of novel biologics, small molecules and medical devices. A talented project manager with extensive background delivering high quality discovery research and contract pharmacology services. Expert is a proactive team leader able to organize, motivate and manage multiple cross-functional teams to achieve performance metrics. Associate is an expert in molecular genetics and stem cell biology with advanced knowledge of experimental models of diabetes, transplantation, vascular disease, and immune modulation. Consultant is a highly collaborative investigator, with strong communication and interpersonal skills, and a solid record of publications in high impact journals. Expert is familiar with current technology trends and compliance issues associated with biologics. This experienced management consultant combines research and strategic business development experience from start-up through VC financing and has contributed at the earliest stages of corporate formation and financing, strategic data mining, competitive intelligence and patent development strategy, and organization and management of cross-functional project teams. Further experience includes facilities design and build-out and pre-clinical product development. This senior scientist and research director combines solid academic credentials with a career of successful SBIR/STTR grantsmanship to fund proof-of-concept and early product development. This consultant is experienced in developing and validating established analytical biochemical and cellular assays, selection of best practices, experimental models and experimental design, and vendor selection. Additional experience includes QC and GLP compliance, contract development, custom proposal preparation, and bidding / budgeting / reporting for biopharmaceutical products. Additional expertise in animal facilities and laboratory design and build-out, operational management, licensing, IACUC organization and training.


Professional Experience:

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in pre-clinical R&D, strategic business development and early product development with advanced knowledge of diabetes and its complications, autoimmunity, metabolic and cardiovascular diseases, and related expertise to a wide variety of clients.

 

Business and Project Management Consultant

Provided key project management and business development consulting services to start-up pharmaceutical, and medical device companies, and established pre-clinical contract research organizations (CROs). Participated in the development of novel chemical entities for post-menopausal women's health, novel a stem cell concentration technology, and promoted specialty diabetes and diabetic complications and cancer models. Recent work experience included: vetting and sourcing world-class CROs and consultants; negotiating in-license agreements and patent development; initiating legal and contractual service agreements; developing and presenting detailed business plans, financial projections and Gantt charts; participating in VC and angel fundraising; applying staged-gate principals to research and project management; designing and performing analytical studies for processing blood; writing grants; authoring posters and powerpoint presentations; and implementing guerilla marketing strategies to expand contract revenues.

 

Business Management Consultant, start-up specialty pharmaceutical company

Promoted a virtual corporate model, dependent on world-class CROs and consultants. Negotiated vital in-license agreement for ESERA technology with Yale Medical School. Initiated all CDA and Master Services Agreements with specialty contract service laboratories, health insurance providers, and prospective payroll and financial consultants. Developed a detailed business plan and Gantt charts with CSO. Helped team raise $500K and developed terms contingent on formation of venture syndicate.

 

Business Management Consultant, start-up medical device company, Boston, MA

Applied staged-gate principals to research, design and validation of patent claims. Performed analytical studies using whole blood and bone marrow samples. Authored poster, powerpoint presentations and patent. Participated in venture capital fund raising initiatives.

 

Business Management Consultant, Biomodels LLC, Watertown, MA

Served this preclinical CRO specializing in cancer and metabolic disease models. Promoted marketing of contract research services through high-visibility, web-based advertising.

 

VP for Research, Research Director

Co-founder of a world-leader in contract research organization, providing custom research services and proprietary rodent models, specialized in diabetes and autoimmune disease, with of >35 FTEs between >35K sq ft of AAALAC accredited facilities. Built a profitable CRO based on discovery research, contract transgenic and lab management services. Funded internal R&D and business growth over 10 years with$30M NIH SBIR/STTR grants and contracts. Mentored and managed a cross-functional research team of 5 PhDs and 1MD and senior technical staff. Served as point person and maintained compliances (OLAW, USDA and IACUC), licenses (DEA, DPH) and directed QC. Served as a liaison with thought leaders in prominent academic institutions, and government officials. Involved in M&A and partnerships to develop novel vaccine technology platform and sustained release formulation of analgesics.

 

Assistant Professor, Depts. of Cell Biology and Pathology, University of Massachusetts Medical School

Research on RNA localization in primary muscle cells funded by 2 MDA grants and a fellowship. Authored nine articles in high impact journals, two invited review articles, and one patent. Presented at international meetings including Gordon Conferences, FASEB and ASCB. Research featured in advanced biology textbooks and on the cover of Journal of Cell Biology. Mentored several post-docs, and a Master's thesis student, and trained several research assistants.

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