Responsible for leading a cross‐functional Global Product Team, in a strong matrix environment. Key interface senior management, including development and presentation of strategic plans and business cases. Works closely with investor relations regarding development of external messages. Responsible for oversight of R&D and commercialization activities to include label expansion efforts, global commercial expansion, and evidence generation. Responsible for Lifecycle management, including cross-functional strategic planning to ensure the greatest success of the brand. Works closely with the Global Project Manager to develop and monitor the various activities within the triple constraint (Scope, Time, Quality) and directs the team on areas of prioritization in line with value creation. Accountable for Program Budget development and management. Works proactively with the team to identify areas of risk to the program, how to mitigate, and development of back-up strategies for accepted risks. In collaboration with the team, presents key stage gates and decisions points to internal governance for discussion and approval.

Strategic role to oversee commercial supply chain operations across two products and a global launch of Orladeyo. Leader of Sales & Operations Planning (S&OP) team. Key partner with Commercial GM’s, Marketing, Business Analytics, Product & Patient Services, Finance, CMC, Quality, and Regulatory for the planning and execution of existing market development and new market launch. Oversight of highly interrelated cross-functional workstreams and their impact to supply chain performance. Member of Product Leadership Team (PLT) and commercial supply chain representative to senior management. Responsible for managing a team of Associate Directors and Supply Chain Operations Managers.

Oversight of commercial supply chain operations and planning. Responsible for the delivery of important therapeutics to a rare disease population in need. Responsible for supporting buildout of the department and infrastructure, including the hiring, onboarding, management and development of commercial supply chain employees. Hands-on role throughout the term based on department infancy and growth. Supported the successful Global Launch of company products.

Management of cross-functional pharmaceutical development projects. Experience managing all aspects of development from preclinical to late stage/commercialization. Served as overall PM for a development program starting with discovery screening through initial IND submission. Served as CMC project lead for a development program. Experience with management of all functional areas including discovery, toxicology, CMC, quality, regulatory. Managed and developed a team consisting of a Project Manager and Document Coordinator. Negotiated business agreements at all stages of development/commercialization.

Management of multiple customer and internal projects for pharmaceutical and medical device development, including international customer projects. Responsible for all aspects of project management/operations within a strong matrix organization. Responsible for development of project plan, timeline, budget, resource analysis, risk analysis, and reporting. Participation in a variety of quality audits, including ISO. Management of cross-functional teams to include formulations, analytical, engineering, manufacturing, quality control, quality assurance, and validations. Collaboration with business development and sales to ensure customer satisfaction and cultivation of project continuation and/or new project approval. Establishment of best practices in Project Management for the department.

Management of multiple customer and internal projects for pharmaceutical and medical device development, including international customer projects. Responsible for all aspects of project management/operations within a strong matrix organization. Responsible for development of project plan, timeline, budget, resource analysis, risk analysis, and reporting. Participation in a variety of quality audits, including ISO. Management of cross-functional teams to include formulations, analytical, engineering, manufacturing, quality control, quality assurance, and validations. Collaboration with business development and sales to ensure customer satisfaction and cultivation of project continuation and/or new project approval.

Member of the Innovation Management/Product Development group. Responsible for development of pharmaceutical and medical device products for external customers; one product currently in clinical trials. Served as the technical lead on several projects to execute formulation development, process development, and clinical manufacturing. Participated in customer visits to present technical project progress, and answer technical questions. Pharmaceutical development work performed on one project resulted in filing and issuance of a US patent.

Member of internal innovation group evaluating acquired and potential intellectual property. Responsible for experimental planning, execution, sample analysis, data review/interpretation, reporting, and preparation of patent example drafts. Provided support for product development in evaluation of proprietary technology, which is currently being used for pharmaceutical products in clinical trials. Evaluation of novel biodegradable polymers for pharmaceutical and medical device use.

Start-up company developing a combination product for use in wound healing applications. Responsible for conducting experiments under supervision of technical lead.

Responsible for the preparation and evaluation of histology samples. Participated in the medical device retrieval program where physicians, scientists, and medical device industry professionals met to review medical device failures and document potential cause/lessons learned.