Job Level: Associate Medical Director, Psychiatry
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.
• Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
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).
• Advanced English level - both written and spoken (mandatory).
• 3 - 5 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.
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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.
