This individual will be required to provide expertise and support to internal and external stakeholders in areas including, but not limited to, clinical pharmacology, pharmacokinetics, drug metabolism, bioanalysis, 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, including contributions to development plans; design, conduct, analysis, interpretation of studies; plan and execute studies to evaluate formulation and reformulation strategies for existing drugs; manage clinical and bioanalytical activities at contract research organizations; identify and work with external consultants to address specific scientific issues; present to internal and external audiences; and write and edit nonclinical and/or clinical portions of publications and regulatory documents. Internally, this individual will serve as an in-house expert on scientific matters and discuss clinical pharmacology, formulation, and pharmacokinetic issues with R&D staff, senior management and regulatory authorities in order to convey key concepts and facilitate understanding of both risks and 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 Medical Affairs, 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: Ph.D. in, pharmaceutical sciences, pharmacology, or related field, or Pharm.D. with clinical pharmacology and pharmacokinetic training and experience. M.S. degrees with applicable experience will also be considered.
Experience: A minimum of 7 years directly related experience in clinical pharmacology, pharmacokinetics, and drug development, preferably in the pharmaceutical industry. Experience with successful FDA submissions and interactions preferred. Clinical research experience preferred. Previous experiences in the pharmacokinetics of drugs used in gastroenterology, dermatology, and/or ophthalmology are also preferred.
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 clinical pharmacology, pharmacokinetics, toxicology, and bioanalytical concepts and results to audiences of varied backgrounds is required. Experience and expertise in using industry-standard pharmacokinetic modeling software is required and familiarity with population modeling is strongly preferred.