Medical Director, Psychiatrist

IQVIA; Durham (NC); Remote; USD 116,000 - 323,000; Full time

Job summary

IQVIA seeks an Associate Medical Director, Psychiatry, primarily acting as a global/regional Medical Advisor and back-up on projects. The role provides medical support to investigative sites and staff for protocol clarifications, eligibility, and patient safety considerations.

Requirements include a medical degree with Psychiatry board certification and 5-7 years in clinical trials. Strong English and Spanish communication is essential as is maintaining an active medical license in the U.S.

Qualifications

• Medical degree from an accredited medical school.
• Psychiatry board certification required.
• 5-7 years of experience supporting clinical trials.
• Fluent in English and Spanish.
• Active medical license in country/region of residence.

Responsibilities

• Act as global/regional Medical Advisor and back-up on projects.
• Provide medical support to sites and project staff on protocol issues.
• Contribute to medical review of protocol, IDB and CRFs.
• Provide therapy-area training to the project team.
• Attend Investigator Meetings and present when needed.
• Review trial-related Adverse Events and SAEs.
• Support AOSE analysis with Pharmacovigilance.
• Review adverse event coding and CSR narratives.
• Participate in Kick-Off and client meetings as required.

Skills

Medical degree

Psychiatry board certification

Clinical trial experience

Bilingual English/Spanish

Regulatory/compliance awareness

Education

Medical degree from accredited school

Specialty board certification in Psychiatry

Job description

Job Level: Associate Medical Director, Psychiatrist

Location: Home-based in the U.S

Job Overview

Primarily acts as global and regional Medical Advisor but may serve as back-up Medical Advisor on assigned projects. Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.

Essential Functions

• Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on assigned projects.
• Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
• May contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
• May provide therapeutic area/indication training for the project clinical team.
• Attends and may present at Investigator Meetings.
• Performs review and clarification of trial-related Adverse Events (AEs).
• May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
• May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
• May perform medical review of adverse event coding.
• Performs review of the Clinical Study Report (CSR) and patient narratives.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

Qualifications

• Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education (mandatory).
• Specialty Board certification in relevant specialty area preferred: Psychiatry (mandatory).
• 5-7 years of prior relevant experience supporting clinical trials, as Investigator, Sub-Investigator, or other related role in Pharma or CRO.
• Current knowledge of medical, scientific and clinical landscape in applicable therapeutic area.
• Good communication, presentation and interpersonal skills in Spanish and English.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Attention to details, flexibility and ability to provide advice on multiple assignments.
• Current and valid country/state medical license or equivalent, from the country or region in which he/she resides and works.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $115,900.00 - $322,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.