To provide leadership to the Clinical Development group covering medical and scientific as well as operational aspects of clinical development. Provide clinical expertise to the strategic development of clinical development plans and supervise all aspects of Phases I-IV Clinical studies including design, execution and reporting; work in partnership with all other relevant development functions during the overall development of new medicines and act as a liaison with Business Development by providing clinical expertise and strategic input and participate in internal and external meetings as requested.
Plan, direct and interpret clinical studies and products (pharmacology, toxicology, and drug metabolism), and clinical trials, and methods of data collection. Facilitate and support the development of products through the various stages of clinical research and development; collaborate with all disciplines within the Company. Establish and approve scientific methods for design and implementation of clinical protocols, data collection and final reports.
Under general direction with periodic review of assignments. Complex work performed within a framework of functional policies and procedures requiring high degree of original thinking.
Education & Experience:
Ph.D., Pharm.D or M.D. in related field or equivalent. At least ten (10) years professional experience in pharmaceutical industry, clinical/medical research, or nursing; involvement in transdermal delivery systems preferred. Experience in working on / leading interdisciplinary product development teams. Knowledge of FDA regulatory requirements and internal SOPs. Previous management or supervisory responsibilities. Computer literate with intermediate knowledge of office application software. Excellent written and verbal communication skills.
Majority of time spent in office environment, operating computer. Occasional exposure to human source products when at study sites.
Visual acuity and manual dexterity required to operate computer and proofread documents.