Key Responsibilities
Medical Strategy & Clinical Documentation
• Collaborate with R&D leadership on medical strategy discussions, ensuring scientific rigor and alignment across the development portfolio.
• Independently draft or review clinical protocols, Informed Consent Forms (ICFs), clinical study reports (CSRs), and Investigator's Brochures (IBs), maintaining the highest standards of accuracy, completeness, and regulatory compliance.
Medical Monitoring & Safety Oversight
• Develop and execute comprehensive medical monitoring plans tailored to each clinical program.
• Conduct ongoing medical review per plan, including eligibility criteria verification, concomitant medication and non-drug therapy assessment, laboratory test/examination review, DLT (Dose-Limiting Toxicity) and MTD (Maximum Tolerated Dose) evaluation, next-cycle dosing eligibility assessment, efficacy evaluation, and adverse event assessment.
• Partner with pharmacovigilance teams to evaluate safety signals, assess overall benefit-risk profiles, and ensure timely SUSAR (Suspected Unexpected Serious Adverse Reaction) case determination and reporting.
Protocol Deviation Review & Compliance
• Review protocol deviations identified during clinical execution and provide timely medical assessments and actionable recommendations.
• Ensure all medical activities adhere to GCP, ICH guidelines, and applicable regulatory requirements.
Medical Review of Clinical Study Reports
• Perform medical review of CSRs, including medical terminology coding, event assessment, clinical commentary, and SUSAR case determination.
• Complete CSR follow-up activities and communicate directly with investigators to resolve data queries — including query generation, review, and dispatch.
Medical Training & Site Support
• Deliver medical training to clinical sites and study teams, including protocol-specific training and therapeutic area education.
• Serve as the primary medical point of contact for the Clinical Operations team, providing real-time guidance on medical questions arising during study execution.
KOL Engagement & External Relations
• Independently engage with, build, and maintain long-term relationships with Key Opinion Leaders (KOLs), investigators, and external scientific advisors.
• Represent the company at scientific conferences, advisory boards, and external stakeholder engagements as needed.
Departmental Standards & Governance
• Lead the development and revision of departmental Standard Operating Procedures (SOPs) and oversee ongoing compliance.
• Champion a culture of scientific excellence, data integrity, and continuous improvement within the medical affairs function.
Team Leadership & Cross-Functional Collaboration
• Lead and develop the medical team (medical writing and medical monitoring), fostering growth, accountability, and high performance.
• Coordinate and collaborate seamlessly with R&D, Clinical Operations, Regulatory Affairs, Pharmacovigilance, and other cross-functional departments.
• Conduct performance evaluations, budget planning, and budget control for all internal medical team projects, ensuring efficient resource allocation and delivery against milestones.
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Qualifications
Education
• Doctoral degree required — PhD or clinical doctorate (MD or equivalent). Bachelor's degree must be in clinical medicine.
• Oncology-related specialization or fellowship strongly preferred.
Experience
• Clinical physician background required — prior clinical practice experience as a licensed physician is essential.
• 5–8+ years of experience in pharmaceutical companies or CROs, with a minimum of 2–3 years in a leadership role such as Medical Manager, Medical Director, or Project Lead.
• Direct experience leading clinical studies in oncology drug development is strongly preferred.
• Proven track record in multi-center clinical trial medical monitoring and project management.
• Experience managing multiple rigorous or complex clinical programs simultaneously is an advantage.
Core Competencies
• Strong strategic thinking, analytical capability, and decision-making skills with the ability to navigate and resolve complex scientific and clinical challenges.
• Exceptional organizational, communication, and coordination skills as a team leader — able to inspire collaboration and drive alignment across functions.
• Creative, collaborative team player with demonstrated ability to thrive under pressure and in fast-paced environments.
• Strong professional writing and oral communication skills, with the ability to convey complex scientific and clinical information to diverse audiences.
• Professional proficiency in English (listening, speaking, reading, and writing).