Medical Director

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

📋 Description

• Take charge of medical design and oversight for significant projects; review and authorize protocols, IB, ICF, SAP, and essential medical documents; contribute medical insights on feasibility, risk mitigation, and endpoint selection.

• Supervise drug safety and management of AEs/SAEs; evaluate medical adjudication and causality assessments; work in collaboration with pharmacovigilance teams and external specialists.

• Offer medical guidance to project teams, biostatistics, and data management; engage in key milestones as requested or according to specific plans.

• Assist with regulatory interactions and ethics committees; draft and review medical position papers, clinical study reports (CSRs), and responses to regulatory inquiries.

• Lead and mentor Medical Monitors and Managers; create capability plans and take part in performance and resource-related decisions.

• Establish and enhance medical governance, quality assurance processes, and standard operating procedures (SOPs) to guarantee high-quality clinical and medical deliverables.

• Act as the company's medical representative in client meetings, support requests for proposals (RFPs), and engage in medical communications with institutional review boards (IRBs), ethics committees, and regulators.

• In certain instances, may assume the role of Safety Physician.

⛳️ Requirements

• Background in Medicine, Pharmacy, or life sciences, with a master's degree or higher preferred.

• At least 10 years of professional experience, including a minimum of 5 years in medical monitoring, medical management, or as a Sponsor preferred.

• Exceptional leadership, cross-functional collaboration, and project management abilities; decisive in a fast-paced environment.

• Proficient in verbal and written English, capable of effective communication with international clients and regulators.

• Ability to work independently and manage multiple tasks concurrently under pressure.

• Proven success in interactions with key opinion leaders and investigators.

• Strong understanding of GCP, ICH, NMPA/FDA/EMA regulations and review processes; experience in pharmacovigilance and regulatory communication.

• Possess a global, cross-cultural perspective and a customer-oriented mindset.

🏝️ Benefits

• Competitive Compensation: A customized salary and benefits package that reflects your skills and experience.

• Flexibility: Enjoy hybrid or remote work arrangements based on your location and role.

• Career Growth: Access to numerous learning opportunities and a global network of scientific leaders to support your professional development.

• Employee Wellbeing: Engage in programs and initiatives aimed at promoting work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.

• Global Opportunities: Join a company with an international presence, providing exposure to a variety of projects and clients.