Medical Consultant Committee Member

Job Purpose:

The Medical Consultant Committee Member will provide independent, professional medical and scientific expert input to support Tigermed’s global medical affairs, clinical development and regulatory related projects. This role acts as an external credible medical advisor for internal cross-functional teams, offering objective scientific guidance for clinical programs, medical initiatives and scientific engagement work.

Collaborate with internal clinical, regulatory, biostatistics, safety, program and operational teams, as well as external vendors and academic partners, to deliver professional medical opinions covering early to late-stage clinical development. Support the construction and optimization of standardized clinical research systems, ensure all clinical activities are delivered within defined scope, budget and timeline, and provide medical compliance suggestions to reduce clinical risks.

Key Responsibilities:

- Deliver independent medical and scientific advice for the design, adjustment and execution of US and global medical affairs plans for all types of pipeline projects and products across multiple therapeutic areas including oncology, cardiology, immunology, ophthalmology, gout & metabolic disorders and medical devices.

- Provide professional medical guidance on clinical study design, patient recruitment strategies and protocol refinement, cooperate with internal clinical development teams to optimize trial feasibility and scientific rationality for both pharmaceutical and medical device trials.

- Review clinical research project execution plans, offer suggestions on quality control standards and clinical progress tracking to guarantee standardized trial implementation across all clinical phases (I–IV).

- Maintain professional academic communication with KOLs, principal investigators, patient advocacy groups and medical professional societies; participate in scientific exchanges and advisory board discussions as a medical expert resource.

- Attend major global medical congresses, scientific forums and academic meetings across diversified therapeutic fields to collect cutting-edge clinical practice, scientific progress and competitor intelligence, and feed insights into internal medical planning.

- Provide medical support for the clinical part of business development initiatives, deliver objective scientific evaluation for potential strategic cooperation projects covering drugs and medical devices.

- Conduct in-depth medical industry and clinical research analysis, output professional medical insights to support the formulation of global professional academic and market activity plans for all therapeutic pipelines.

- Draft, review and conduct compliance review of all medical and scientific materials (for drugs and medical devices), verify the accuracy, scientific rationality and regulatory compliance of medical content.

- Deliver targeted medical and scientific training for internal clinical, operation and regulatory teams to unify standardized scientific messaging and clinical judgment logic across all therapeutic areas.

- Independently conduct medical risk assessment for clinical trials of drugs and medical devices, put forward targeted risk mitigation suggestions covering study design, patient safety and post-market clinical follow-up.

Qualification Requirements:

1. Education Background: MD or equivalent recognized medical degree; solid systematic clinical training and profound professional medical knowledge in clinical practice.

2. Industry Experience: Minimum 5 years of professional clinical development experience in pharmaceutical, biotech or CRO industry, covering full-cycle clinical activities across Phase I–IV for drugs or medical devices.

3. Clinical Research Background: Rich working experience in academic medical research institutions or biopharma/medical device industry clinical development; capable of independently interpreting, analyzing and presenting clinical trial efficacy and safety data, as well as basic scientific research reports.

4. Therapeutic Area Coverage: Professional clinical expertise covering multiple therapeutic areas (including but not limited to oncology, cardiology, immunology, ophthalmology, gout & metabolic disorders, and medical devices); experience in cell therapy, immuno-oncology, hematologic malignancies or device clinical trials is preferred.

5. Industry & Regulation Knowledge: Comprehensive understanding of full lifecycle drug/medical device development and global multi-region clinical trial design rules (from pre-clinical discovery to registration and post-marketing surveillance); familiar with US FDA, global mainstream clinical regulatory compliance requirements and local healthcare operation environment for both pharmaceuticals and medical devices.

6. Soft Competencies: Excellent written & verbal communication skills, strong interpersonal coordination and cross-team collaboration capabilities; rigorous logical thinking, independent objective judgment and outstanding document review ability.

7. Preferred Qualifications: Served as principal investigator / sub-investigator for multi-center clinical trials of drugs or medical devices; past experience as medical expert / committee consultant for CRO or biotech/medical device enterprises.