Company Description

I-Mab (Nasdaq: IMAB) is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal discovery and global partnerships for in-licensing, based on the Company's Fast-to-Proof-of-Concept and Fast-to-Market development strategies. The Company is progressing from a clinical stage biotech company into a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

Job Description

The clinical biomarker lead is responsible for the overall quality of biomarkers to be implemented in clinical studies and its execution with collaboration with clinical team by managing CROs. The position will report to the head of US Site and is based in Maryland.

Major responsibilities:

1. Participate in the design and implementation of biomarker research in clinical trials and monitor the scientific quality of pharmacodynamic and predictive biomarker clinical assay data
2. Collaborate with medical directors, clinical pharmacologists, nonclinical and discovery research scientists to ensure agreement on biomarker needs for clinical development strategy. Part of the team that provide strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated translational research strategy for assigned programs.
3. Supervise external research collaborators and contractors (CROs) to implement the biomarker research in clinical trials and function as the key contact person that manage the performance of CRO service to ensure the deliverable in a well-controlled manner
4. Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols and documents submitted to regulatory affairs

Qualifications

• Ph.D +10 years, or PharmD +12 years, or Masters +13 years or Bachelors +15 years of experience. Degree is expected in relevant scientific area, e.g., Immunology, Pharmacology, Biochemistry, Molecular Biology, Cell Biology. More than 5 years of relevant industry experience in clinical biomarker
• Recognized expertise in biomarker discovery and development as demonstrated by publications, regulatory submissions and/or national or international presentations
• Must be capable of utilizing the highest scientific and technical standards for the successful design and execution of clinical biomarker strategies implemented in early clinical programs in a timely manner
• An understanding of clinical concepts, trial design and implementation of biomarkers
• Excellent understanding of drug development, regulatory processes and clinical development
• Strong leadership abilities and proven ability to lead a team of bioanalytical and biomarker scientists
• In-depth experience managing the relationship with CRO

Additional Information

All your information will be kept confidential according to EEO guidelines.