POSITION 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.

DUTIES AND RESPONSIBILITIES:

• 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 and oversees and manages other PI colleagues and clinical personnel including Sub Investigators.
• 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
• 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.

Supervisory Responsibilities: 

Manages medical responsibilities and medical supervision of the 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. In coordination with the Executive Director, CRU Services, responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Competencies:

• Timely Decision Making: Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision.
• Managing and Measuring Work: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; monitors process, progress, and results; designs feedback loops into work.
• Organizational Agility: Knowledgeable about how organizations work; knows how to get things done both through formal channels and the informal network; understands the origin and reasoning behind key policies, practices, and procedures; understand the cultures of organizations.
• Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources.
• Strategic Agility: Sees ahead clearly; can anticipate future consequences and trends accurately; has broad knowledge and perspective; is future oriented; can articulately paint credible pictures and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans.

JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:

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.
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.

KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED

Certificates and Licenses: 

Current unrestricted license to practice medicine in the State of California. Advanced Cardiac Life Support (ACLS) certification. Columbia-Suicide Severity Rating Scale (C-SSRS) training is required and will be provided by the company. GCP training is required and will be provided by the company.

Language Ability:

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.

Math Ability:

Ability to comprehend and apply principles of modern algebra and advanced statistical theory.

Reasoning Ability: 

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

Computer Skills: 

To perform this job successfully, an individual should have advanced knowledge and experience using the current MS Office Word and Excel.

Work Environment:

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.

Physical Demands:

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.

CONDITIONS OF EMPLOYMENT

• Verification of educational requirements, employment history, professional references, and certifications/training and U.S. work authorization.

WORKING CONDITIONS AND PHYSICAL EFFORT

• Work is normally performed in a typical interior/office work environment, remotely or in a hybrid arrangement based on approval from the department manager/supervisor.

The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.