Position: (Associate) Medical Director
Work Style: Fully Remote
Responsibilities
Oversee medical aspects of clinical studies to minimize risk, including:
Medical monitoring of adverse events
Laboratory abnormalities
Changes in patient status
Protocol eligibility
Concomitant medication assessments
Review of unblinding requests
Review and evaluate serious adverse events in accordance with relevant regulations, ICH guidelines, internal SOPs, and project‑specific procedures.
Provide medical judgment and decision-making across internal medical teams, project teams, investigators, and external clients.
Act as a medical consultant regarding protocol-related inquiries and provide therapeutic/protocol training to study teams as needed.
Conduct safety reviews and data listing checks based on contract requirements and data validation plans, including identifying potential safety signals using patient profiles and other tools.
Support regional and global clinical trials, including studies that involve Japan.
Contribute to medical training, investigator/KOL engagement, business development support, and client‑facing activities, including occasional in‑person meetings.
Required Qualifications
MD (Doctor of Medicine) with an active medical license
Minimum 2 years of clinical experience in a hospital setting
Preferred backgrounds: Neurology, Oncology, General/Internal Medicine
Ability to work effectively within Japan-based as well as regional/global teams
Fluency in both Japanese and English
Preferred Qualifications
Experience interacting with regulatory authorities and/or working within the pharmaceutical industry
Work Location
Fully Remote