Summary: Ensures safe, reliable, and successful conduct of clinical drug research through the direction and coordination of activities and functions of the medical department by performing the following duties personally or through subordinate supervisors. In addition, establishes and develops the area of cardiometabolic research as a line of complimentary clinical and scientific research services at ProSciento. Performs duties in accordance with company’s values, policies and procedures.
Essential Duties and Responsibilities include the following. Other duties may be assigned at the Company’s sole discretion.
Evaluates proposed clinical trials for scientific value, ethical considerations, and feasibility in conjunction with clinical management team.
Assesses and plans future clinical human resource and process needs.
Manages and oversees clinical aspects of human trials at ProSciento.
Serves as Principal Investigator for clinical studies at ProSciento.
Supports protocol development, study report development, and preparation as needed.
Interfaces with pharmacy staff on study needs and conduct.
Acts as liaison between clinical operations and project management.
Evaluates clinical training needs for ProSciento and for studies.
Develops appropriate clinical training curriculum in conjunction with quality assurance and clinical operation departments.
Maintains and oversees training program for all clinical staff.
Maintains communications with sponsors during the conduct of the clinical trials.
Develops and implements policies for interface between clients and clinical activities.
Provides primary oversight of clinical resources, determining physician and clinical resource needs and utilization within the clinic.
Supervises the conduct of clinical trials for accuracy and efficacy in accordance to the highest clinical research standards (GCP/ICH) standards, clinical standards, and to all applicable FDA regulations.
Provides leadership, fosters team building, positive communication, and corporate culture within the medical team.
Additional Responsibilities for Medical Director:
All duties defined above, and in addition:
Responsibility for employee health assessments.
Participates in business development and client liaison activities.
Oversees the development of appropriate clinical training curriculum in conjunction with quality assurance and the clinical operations department.
Manages medical department. Is responsible for the overall direction, coordination, and evaluation of this unit. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Associate Medical Director:
Medical degree and/or equivalent. 3-5 years related experience and/or comparable experience in a director or supervisory role. Experience with technical, clinical, regulatory, and managerial aspects of clinical drug research and as a principal/sub-investigator with various drug studies. Experience with current standards of Good Clinical Practice and familiarity in working with FDA, DEA, ICH, state, and other regulations relevant to the conduct of clinical drug research.
Medical degree and/or equivalent. 5 years related experience in a director or supervisory role. Experience with technical, clinical, regulatory, and managerial aspects of clinical drug research and as a principal/sub-investigator with various drug studies. Experience with current standards of Good Clinical Practice and familiarity in working with FDA, DEA, ICH, state, and other regulations relevant to the conduct of clinical drug research.
Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to inquiries or issues. Ability to create written documentation and/or articles assimilating scientific data into comprehensive formats. Ability to make effective and persuasive speeches and presentations on complex topics.
Ability to comprehend and apply principles of modern algebra and advanced statistical theory.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format
To perform this job successfully, an individual should have advanced knowledge and experience using the current MS Office Word and Excel.
Certificates and Licenses:
Current unrestricted license to practice medicine in the State of California. Advanced Cardiac Life Support (ACLS) certification.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
Internal Number: 1048
About ProSciento, Inc.
ProSciento is a leading specialty clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity and related metabolic diseases. Building on 15 years of experience and more than 280 metabolic clinical projects conducted, ProSciento provides customized clinical research services for multinational, early development clinical trial programs designed to give our clients an advantage in today’s rapidly evolving landscape of metabolic drug and device development.
For more information, please visit www.prosciento.com