医学经理/高级经理

该职位来源于猎聘 Key Responsibilities

• Clinical Trial Strategy & Protocol Design
• Document Authoring: Lead or significantly contribute to the development of key clinical documents, including Clinical Trial Protocols (CTPs), Protocol Amendments, Investigator’s Brochures (IBs), and Clinical Study Reports (CSRs).
• Data & Endpoint Input: Provide medical input into the design of eCRFs, data management plans, and statistical analysis plans (SAPs) to ensure specific cardiovascular/metabolic safety and efficacy endpoints (e.g., biomarkers, imaging, cardiovascular outcomes) are captured.
• Competitive Intelligence: Conduct literature reviews and analyze competitor pipelines to support the Target Product Profile (TPP) and clinical development strategy.
• Medical Monitoring & Patient Safety
• Study Oversight: Serve as the Primary Medical Monitor for assigned studies, evaluating protocol eligibility, reviewing protocol deviations, and answering medical queries from investigational sites.
• Signal Detection: Perform continuous safety reviews; track laboratory trends, AESIs, and potential safety signals (e.g., liver signals, DILI, Hy's Law assessments).
• PV Collaboration: Partner closely with PV to evaluate SAEs and ensure timely reporting to global regulatory authorities.
• Regulatory & Submission Support
• Dossier Preparation: Support the preparation of clinical sections for regulatory submissions (e.g., CTA, IND, NDA, MAA).
• Regulatory Defense: Participate in meetings and defend clinical data packages before regulatory bodies (such as the CDE, FDA, or EMA).
• Cross-Functional Leadership & Trial Operations
• Matrix Representation: Represent the Medical function at the Clinical Review Committee (CRC) and cross-functional study team meetings.
• Site & PI Partnerships: Partner with Clinical Operations to identify, evaluate, and select high-potential investigational sites, leveraging personal relationships with top-tier institutions to accelerate site activation and patient recruitment.
• Clinical Training: Provide therapeutic and protocol-specific training to internal teams (Clinical Operations, Data Management, CRAs) and external partners (CROs).
• KOL Network Engagement & Scientific Advisory
• Network Cultivation: Establish, foster, and maintain a robust network of domestic and international Key Opinion Leaders (KOLs), Scientific Advisory Boards, and Principal Investigators (PIs) within the CV/Metabolic space.
• Insight Gathering: Leverage KOL relationships to gather external scientific insights, validate clinical development strategies, and optimize protocol feasibility.
• Advisory Management: Organize and lead Medical Advisory Boards, Investigator Meetings, and scientific panels to present data and secure expert alignment on study designs. Qualifications & Experience
• Education: Medical Degree (MD or equivalent) is required. Board certification or clinical practice experience in cardiology, endocrinology, internal medicine, or metabolic health is highly preferred.
• Experience Profiles: Manager Level: 2–4 years of clinical development experience within a pharmaceutical, biotech company, or leading global CRO, with exposure to CV/metabolic pipelines. Senior Manager Level: 5+ years of industry experience with a proven track record of leading complex trials (e.g., Phase 1 First-in-Human trial, large Phase 2/3 global/regional trials in dyslipidemia, thrombosis, obesity or NASH/MASH, etc.).
• Technical Skills: Technical Skills: Deep understanding of GCP, ICH guidelines, and global/local regulatory frameworks (such as CDE guidelines). Strong capability in safety signal detection, medical data review, and contributing to Investigator’s Brochure (IB) and safety updates.
• Languages: Fluent in written and spoken English and Mandarin, with excellent medical writing and presentation skills.