Overview

The part-time Medical Director will manage the Medical Department and provide qualified services and support during clinical development and submission, including medical writing, medical consulting, medical monitoring, and supporting drug safety. This role will oversee the performance of the medical monitoring team, as well as have extensive cross-functional interaction, including clinical, regulatory, and commercial functions.

Responsibilities

Essential Job Functions as Individual Contributor:

• Establish and maintain reliable and professional relationships with regulatory authorities and medical KOLs.
• Provide medical expertise in the review of adverse events and pharmacovigilance activities.
• Supervise the medical and safety monitoring activities of clinical studies, including but not limited to medical support of enrollment activities, protocol deviation management, data review of clinical lab values, and adverse events and medical coding.
• Responsible for the timely and accurate completion of project documents, such as protocols, ICFs, as well as clinical study report and amendments.
• Responsible for any medical-related project activities and project progress as planned, agreed, and achieved.
• Provide project-specific and therapeutic training to sponsors and employees, as needed.
• Collaborate with Quality Assurance and Regulatory Affairs teams to establish and maintain strong risk assessment and risk management processes for decision-making.
• Conduct medical safety relevant tasks according to regulation and procedural documents, including product safety monitoring, safety review, and preparation of safety report, Risk Management plan, DSUR, PSUR, RCP, etc., as needed.
• Collaborate with Medical Director/Manager (when Safety Physician and Medical Monitor are not same person on project) and DS personnel.
• Provide in-depth evaluation and solutions for safety issues.
• Provide medical input for project proposals and support Bid Defense meetings as needed.
• Responsible for other duties as assigned, including but not limited to business development, customer communication, staff recruitment, and training.

Qualifications

Experience / Education

• Minimum of a Doctorate of Medicine degree with specialty in Oncology required.
• Minimum of 10 years' experience in clinical development-focused in Oncology research phase 1-4.

Knowledge / Skills / Abilities:

• Advanced knowledge of pharmacovigilance regulations, including Good Clinical Practice (GCP) guidelines.
• In-depth knowledge of Food and Drug Administration (FDA) and worldwide drug-development regulations.
• Proven leadership record with the ability to motivate and inspire people, as well as build teams.
• Experience working with high-performing teams and demonstrated ability to collaborate, facilitate, influence, and organize across time zones in a global organization.
• Excellent interpersonal skills with a demonstrated ability to develop networks and maintain business relationships.
• Ability to work independently and handle multiple tasks simultaneously and under pressure.
• Knowledge of global, cross-cultural perspectives.
• Proficient oral and written communication skills in English are required. Mandarin a plus.
• Strong ethics and integrity with demonstrated ability to prioritize tasks and manage time effectively.
• Proficient in Microsoft (Excel, Word, Outlook).

Physical Requirements:

• Ability to stand /Sit/walk for long periods of time
• Ability to crouch, bend, twist, and reach
• Ability to travel via plane or train

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, or protected veteran status and will not be discriminated against on the basis of disability