Summary: Under general direction, establishes and executes clinical research programs for the clinical evaluation of products to meet the strategic objectives of the organization. Coordinates efforts to develop studies designed to meet regulatory registration and marketing objectives. Supervises assigned department staff.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
* Carries out managerial responsibilities in accordance with the organization?s policies, procedures, and state, federal and local laws.
* Oversees, directs, coordinates and prioritizes the daily activities of a project specific Clinical Research Department and assigned staff.
* Formulates strategies, prioritizes tasks, and develops timetables for conducting project specific clinical trials.
* Identifies critical issues that impact the quality of research programs and resources. Implements corrective action when necessary.
* Monitors and administers all activities involved in project specific clinical trials in order to ensure compliance with federal regulations and Standard Operating Procedures (SOPs). Includes establishing overseeing budgets, project timelines, and summary reports. Ensures project deadlines and performance standards are met.
* Develops, evaluates and implements a safety-monitoring program.
* Assists with the development of and supports departmental operational procedures and systems.
* Interacts with contract research organizations (CRO). Investigators, consultants, vendors, and advisory boards to facilitate product development and support marketing efforts.
* Interfaces with regulatory authorities to explain/defend the planned and executed clinical research studies.
* Directs the staffing and resource planning/allocation across all clinical projects.
* Reviews and approves documents generated by clinical research including but not limited to protocols, study reports and regulatory documents supporting INDs, NDAs and FDA information requests.
* Directs, reviews and audits Phase I ? Phase IV studies.
* Oversees, participates and approves the interviewing, hiring, and training of departmental employees; conducts performance evaluations for direct reports; and assists direct report managers with performance evaluation process for their units.
* Provides support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.
* Ensures compliance with all Company policies and procedures, including safety rules and regulations.
* Performs related duties as assigned.
Required Knowledge and Skills:
* Pertinent Federal and State laws related to Pharmaceutical industry, Current FDA and Drug Enforcement Agency clinical requirements.
* Business, scientific and personal computer hardware and software applications.
* Current clinical research procedures and practices, additions/deletions.
* Therapeutics, pharmacokinetics, biostatistics and data management principle and practices.
* Business English usage, spelling, grammar and punctuation.
* Principles and practices of budget preparation and administration.
* Administration, supervision and training practices and methods.
* Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.
* Current Company policies, practices and procedures, including safety rules and regulations.
* Responding to sensitive and complex inquiries from management, employees and regulatory agencies.
* Preparing, presenting and administering budgets and financial reports.
* Communicating clearly and concisely, both orally and in writing.
* Operating computers.
* Managing multiple projects, duties and assignments.
* Interpreting and applying Federal, state and local policies, procedures, laws and regulations.
* Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.
* Establishing and maintaining cooperative working relationships with others.
* Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, keyboard operation monitor viewing, moderate noise levels and business travel. Work is performed in an office environment.
Minimum Qualifications: Bachelors degree in a scientific/technical or related field from an accredited college or university, and ten (10) years pharmaceutical/clinical experience, including four (4) years in a supervisory or management capacity or an equivalent combination of education and experience. Graduate level degree preferred.