The Associate Director, Clinical Pharmacology position reports to the Director, Non-Clinical Development R&D having the following responsibilities.
The candidate will be working primarily to support development projects in Immuno-inflammatory/Oncology diseases, including the design, implementation, and reporting of clinical pharmacology studies (DDI, TQT, hepatic/renal insufficiency, BA/BE, etc.) based on applicable regulatory requirements. These activities include establishing PK/PD clinical plans, performing PK/PD analysis, authoring clinical pharmacology sections of clinical study reports (CSR) and all applicable worldwide regulatory documents (IB, IND, NDA, MAA, etc.). The candidate will be responsible for designing/planning/monitoring/reporting of Clinical Pharmacology studies in collaboration with Clinical Research and Nonclinical Drug Development.
The candidate will possess a significant understanding of clinical PK and PK/PD concepts and applications as well as have knowledge of drug metabolism, physiology, and human and animal studies for drug development programs.
This position will work closely with clinical, nonclinical, regulatory, and project management and advise project teams and management on the clinical pharmacology programs for all development projects and take part in communicating study design and results with domestic and foreign regulatory agencies.
Essential Duties and Responsibilities:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is occasionally required to stand, walk, use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear.
The employee must occasionally lift and/or move objects up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
Required Education and Experience: