Associate Medical Director-Auto Immune

This role is responsible for providing medical expertise on different stages of clinical trials to accelerate the fast growth of Duality. Including study design, protocol development, execution, medical monitoring, as wellcontributing to clinical development planning and strategy.

Requirements:

1. Leads the development of clinical development plans, proof-of-concept strategies, and registration strategies for oncology projects;

2. Leads the development of clinical study protocol synopses, protocols, and protocol amendments, including providing inputs in study design and scientific justifications;

3. Leads clinical intelligence and development strategy；

4. Leads clinical development decisions: Building a pipeline specific intelligence database by diseases and targets, and renewing by quarter;

5. Generating competitive landscape reports, internal data analysis reports as needed, and supporting leadership decision-making at key milestones in clinical developments;

6. Formulating clinical intelligence and strategic analysis to assist decisions of the key points in clinical development;

7. Contributes in the clinical sections of the IND/NDA/BLA CTD, briefing packages for regulatory meetings and lead the development of IB, CSR, publications and other relevant clinical documents;

8. Reviews and provides clinical input across different study documents including ICF, CRF, medical monitoring plan, data transfer specifications, etc.

9. Answers to medical questions raised by EC/IRBs and sites; identifies the need of protocol amendment and maintains appropriate compliance with protocols;

10. Leads or participates in the elaboration of training material and presentations at the investigator meetings, advisory committee meetings, and steering committee meetings;

11. Conducts literature research and competitive intelligence tracking for assigned projects;

12. Performs all duties in keeping with the company’s core values, policies and all applicable regulations;

Qualifications:

Master degree and above with Immunology, Medical, Life science or related major and clinical experience in Immunology.

Physician and Ph.D background is preferred

At least 5 years of experience in clinical research or relevant experience, clinical trials experiences preferred

Strategic thinking by actively seeking information to develop optimal clinical development strategy for registration

Advanced disease knowledge is preferred with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level

Excellent verbal and written skills in English

Skills in communication, problem-solving and risk management