This individual will be required to provide expertise and support to internal and external stakeholders in areas including, but not limited to bioanalysis, clinical pharmacology, pharmacokinetics, drug metabolism, and/or nonclinical pharmacology.
The Research and Development (R&D) portfolio covers many different areas including treatments for diseases and disorders in gastroenterology, dermatology, and ophthalmology. The portfolio also includes both small molecules and biopharmaceuticals (biologics). This position will provide clinical and/or nonclinical support for the R&D portfolio, with a direct emphasis on managing and evaluating external bioanalytical activities at contract research organizations; overseeing conduct at labs and performing pharmacokinetic analysis of data; aid in the execution of nonclinical and clinical studies for existing drugs; manage some clinical activities, e.g. clinical sample analysis; work with external consultants to address bioanalytical issues; present to internal and external audiences. Internally, this individual will serve as an in-house expert on scientific matters relating to bioanalysis and pharmacokinetics, and may be responsible for communicating bioanalytical and/or pharmacokinetic issues with R&D staff or senior management in order to convey key concepts and facilitate understanding of results.
This position will be responsible for professional, first-line impression of the Company through interaction via telephone, written correspondence, and presentations. This individual should expect daily interactions with senior level staff members including, but not limited to, the Heads of Research and Development, Regulatory, Clinical, and their direct reports.
This position requires the ability to act independently and to take initiative with minimal supervision from their manager. Also, this individual will be required to advise their manager of work schedule, priorities, problems, and planned and unplanned absences.
Education: Bachelor’s, Master’s, or Ph.D. in, pharmaceutical sciences, pharmacology, analytical sciences, or related field with some clinical pharmacology and pharmacokinetic training and experience.
Experience: A minimum of 1 year with Ph.D or a minimum of 5-10 years for Bachelor’s and Master’s degree holders with experience in bioanalysis, clinical pharmacology, pharmacokinetics, and/or drug development, preferably in the pharmaceutical industry; relevant academia experience will also be considered. Previous experiences in the bioanalysis (including method development and validation) of small molecules with LC-MS/MS or immunoassays for biologics are required. Previous experiences with gastroenterology, dermatology, and/or ophthalmology are also preferred, but not required.
Skills and Abilities: Strong interpersonal, teamwork, organizational and workload planning skills, as well as excellent written and verbal communication skills are required. Leadership skills, initiative, attention to detail and accuracy, and an overall commitment to excellence are required. Proficiency in discussing bioanalytical concepts, pharmacokinetics, and scientific results to audiences of varied backgrounds is required. Experience and expertise industry-standard pharmacokinetic modeling software is preferred, but not required.