Sharon C. Spence
Sharon Spence has over twenty years of experience in drug development, primarily in clinical operations, project planning and project management. She has been consulting in the pharmaceutical industry since 2001.
As a consultant, Sharon has worked with a variety of companies at all stages of development. She has participated in due diligence efforts with start-up companies and venture capital groups to assess and acquire new technologies for development. She has provided operational input to strategic plans and has written development plans (program and clinical), set up project teams, and identified resources (internal and external) to allow companies to initiate and continue their drug development programs. She has planned and participated in pre-IND meetings, IND filings and NDA-related planning and execution efforts.
Prior to her consulting role, Sharon worked for large and small pharmaceutical companies in the development of small molecules and biologics. She began her clinical research career at Johnson & Johnson, where she assumed increasing levels of responsibility, eventually managing the overall clinical operations of a multinational biologic program. After leaving J&J, she was the Director of Clinical Operations for ImmuLogic (1994-1997), a small start-up company in Waltham, MA. As the Director of Clinical Operations for LeukoSite (Cambridge, MA; 1997-2001) she had responsibility for all clinical operations activities for six development programs. She managed the clinical efforts for the filing and approval of CAMPATH. After the merger of LeukoSite with Millennium Pharmaceuticals (1999), she continued her role within that organization as Senior Director of Clinical Operations. As part of the senior management team, she was involved in the early efforts to transition Millennium from a research organization to a development company, including the establishment of development project teams, and incorporation of clinical development activities into financial and strategic planning for the company. During this time, the clinical development group underwent significant expansion to establish in-house drug development capabilities.
Sharon earned a Masters degree in organic chemistry at Duke University and began her pharmaceutical career as a bench chemist at Burroughs-Wellcome.
As a consultant, Sharon has worked with a variety of companies at all stages of development. She has participated in due diligence efforts with start-up companies and venture capital groups to assess and acquire new technologies for development. She has provided operational input to strategic plans and has written development plans (program and clinical), set up project teams, and identified resources (internal and external) to allow companies to initiate and continue their drug development programs. She has planned and participated in pre-IND meetings, IND filings and NDA-related planning and execution efforts.
Prior to her consulting role, Sharon worked for large and small pharmaceutical companies in the development of small molecules and biologics. She began her clinical research career at Johnson & Johnson, where she assumed increasing levels of responsibility, eventually managing the overall clinical operations of a multinational biologic program. After leaving J&J, she was the Director of Clinical Operations for ImmuLogic (1994-1997), a small start-up company in Waltham, MA. As the Director of Clinical Operations for LeukoSite (Cambridge, MA; 1997-2001) she had responsibility for all clinical operations activities for six development programs. She managed the clinical efforts for the filing and approval of CAMPATH. After the merger of LeukoSite with Millennium Pharmaceuticals (1999), she continued her role within that organization as Senior Director of Clinical Operations. As part of the senior management team, she was involved in the early efforts to transition Millennium from a research organization to a development company, including the establishment of development project teams, and incorporation of clinical development activities into financial and strategic planning for the company. During this time, the clinical development group underwent significant expansion to establish in-house drug development capabilities.
Sharon earned a Masters degree in organic chemistry at Duke University and began her pharmaceutical career as a bench chemist at Burroughs-Wellcome.