Provides medical leadership, oversight, and management of human clinical trials while ensuring the integrity of the studies and the safety and well-being of human subjects. Performs duties in accordance with company’s values, policies, and procedures.

DUTIES AND RESPONSIBILITIES:

Clinical trials:

• Participates in clinical trials as Principal Investigator and Sub-Investigator.
• Provides input to the science team for protocol development.
• Reviews and edits, as needed, all key study documents, including study protocols, Investigator Brochures, statistical analysis plans (SAP), tables, listings, and figures (TFLs) for statistical analysis, dose escalation reports, clinical study reports (CSR), abstracts and papers for scientific publication.
• Supports planning and preparation for new clinical trials, including development of study training materials.
• Supports protocol training of the clinical operations staff.
• Participates in regular study meetings with staff and sponsors.
• Leads or participates in data review and discussions regarding results, including dose escalation meetings and clinical interpretation meetings.
• Supports Business Development as needed in sponsor interactions, including protocol development meetings, sponsor site qualification visits, and sponsor audits.
• Participates in FDA or other regulatory body audits as required.
• Attends conferences to present study results as required.

Screening:

• Performs medical histories, physical exams, and protocol-based assessments for qualification of subjects for studies.
• Determines suitability of study volunteers for enrollment.

Clinic activities:

• Admits, discharges, and monitors subjects including reviewing lab results, EKG’s, and telemetry.
• Reviews training documents and completes any accompanying quizzes.
• Supervises mid-level practitioners.
• Assesses and manages adverse events and medical emergencies.
• Participates in safety and dosing assessments.

On call responsibilities:

• Shares in rotation of weekly call schedule.

Supervisory Responsibilities:

Supervises and oversees mid-level practitioners’ medical and safety clinical conduct. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Supervises the overall conduct of studies when serving as Principal Investigator for the studies.

JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:

Qualifications:

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.

Research Physician Education and Experience:

Medical degree plus at least one year of clinical experience in adult medicine. Experience in clinical trials and/or drug development preferred.

Certificates and Licenses:

Current unrestricted license to practice medicine in the state of California. Board certification in Internal Medicine, Family Medicine, Endocrinology, Gastroenterology or Emergency Medicine are strongly preferred. Other specialties may be acceptable depending on background clinical experience. Current Advanced Cardiac Life Support (ACLS) certification or ability to be certified within one month of employment. 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.

KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED

Skills, Knowledge, and Abilities:

Knowledge of current principles, methods, and procedures for the delivery of medical evaluation, diagnosis, and treatment. Understanding of basic physiology of glucose homeostasis, diabetes, and obesity. Ability to manage medical care of diabetic subjects, obese subjects, and other common medical problems, including medical emergencies. Thorough understanding of Good Clinical Practices (GCP) and FDA regulations governing conduct of clinical trials. Must be willing and able to take call and work weekend shifts.

Language Ability:

Ability to read and interpret documents such as safety rules, Standard Operating Procedures (SOPs), Work Instructions (WIs), procedural manuals, governmental and clinical regulations, and similar documents. Able to communicate effectively to employees and management groups and in group meeting settings. Must be able to communicate effectively with sponsors and vendors.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.

Reasoning Ability:

Good judgment, initiative, problem solving and leadership skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

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

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.
• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Informing: Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit, and/or the organization; provides individuals information so that they can make accurate decisions; is timely with information.
• Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.
• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.

CONDITIONS OF EMPLOYMENT

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