Sr Director Cmc
CurrentKey driver in developing product strategies from discovery to commercial scale, providing thelink between ideation to product development and clinical research. Build, lead and mentor internal development resources (team, networks, vendors, budgets, etc.)and manage projects with external vendor services. Identify, select, direct, manage and support outsourced vendor contracts for the successfuldevelopment of novel products including domestic and international CROs/CMO/CDMOs. Thisincludes understand and managing supply chain matters (import, export, distribution) andscheduling matters, as compounds may be controlled by DEA and similar agencies in variousjurisdictions using strong understanding of ICH and GxP requirements for pharmaceuticaldevelopment. Establish and maintain relationships with outside scientific experts in relevant disciplines tosupport the current and future planned R&D activities. Expand expertise in new drug design, druggability (phys-chem) evaluations, quality control, in vitro and in vivo testing as needed to help in candidate selection. Represent the company at scientific and industry meetings and describe the company's productsand research to internal and external stakeholders including partners, investors, collaborators,and regulatory agencies.