Senior Medical Director, Medical Monitor

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• Oversee medical aspects of clinical trials to guarantee adherence to company SOPs, client directives, good clinical practices, and regulatory standards.

• Manage all medical responsibilities related to contracted activities throughout the pharmaceutical product lifecycle.

• Ensure that tasks assigned to Pharmacovigilance are executed effectively.

• Comply with relevant regulations, ICH guidelines, client SOPs/directives, project-specific WPDs, and corporate policies.

• Offer medical consultation to team members and address study-related medical inquiries.

• Deliver therapeutic and protocol training for assigned studies.

• Assist in the preparation and/or evaluation of CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related documentation.

• Participate in departmental process enhancement initiatives.

• Monitor safety parameters, including adverse events, laboratory abnormalities, patient medical status, concomitant medications, and un-blinding requests.

• Discuss medical issues with principal investigators and clients, and support clinical decision-making processes.

• Conduct medical reviews of adverse events of special interest, serious adverse events, and clinical outcome events.

• Execute contracted data review and validation, including coding listings and/or comprehensive safety data.

• Oversee signal detection activities and prepare aggregate reports.

• Contribute to label updates, dossier maintenance, and risk management efforts.

• Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources.

• Attend and present at investigator and sponsor meetings.

• Provide medical consultation to clients, investigators, and project team members.

• Assist in business development initiatives.

⛳️ Requirements

• MD or an equivalent degree is mandatory.

• Active medical licensure is preferred.

• Clinical experience treating patients in hema oncology or a related sub-specialty, approximately 2 years.

• Relevant clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator, around 1–2 years; or direct experience in safety/Pharmacovigilance, equivalent to 2 years.

• Extensive knowledge or specialized expertise in the relevant functional area.

• Capability to devise solutions to highly intricate and unique problems.

• Ability to exercise independent judgment regarding methods, techniques, and evaluation criteria.

• Skill to act as a consultant and spokesperson on highly significant matters.

• Proficiency in establishing formal networks with key decision-makers.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.