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 well contributing to clinical development planning and strategy.
Responsibilies:
Lead the development of clinical development plans, proof-of-concept strategies, and registration strategies for oncology
projects; keep the CDP up to date by regular review per business needs
Oversight or leads the development of clinical study protocol synopsis, protocols, and protocol amendments, medical documents, such as IB, CSR, MMP etc. Review and approve other function documents that need medical input, such as ICF, CRF, PD documents, SAP, DVP, dry run, DSUR etc. Contributes to the clinical sections of the IND/NDA/BLA CTD, briefing packages for regulatory meetings;
Lead or conduct medical monitoring to ensure data review quality (e.g., participant eligibility review, Protocol Deviation
review, efficacy and safety review such as efficacy variable; AEs; Concomitant medications), participant safety and data accuracy;
Ensure comprehensive safety review and safety follow up;
Where possible (appropriate language skills exist), check critical items in the translation (e.g., clinical/preclinical
research terminology) and provide comments back to the translation vendor;
Oversee function-related vendor selection and supervise medical related work regardless of whether it is implemented in-house or out-sourcing to third party organizations;
Answers medical questions raised by HA/EC/IRBs and sites; identifies the need for protocol amendment and maintains appropriate compliance with protocols;
Lead or participates in the elaboration of training material and presentations at the investigator meetings, advisory committee meetings, and steering committee meetings;
Establish good relationship with KOLs and set up the regular or ad hoc ad board and consultation meeting;
Report the team key
progress, key issues/actions to the compound Leader and company senior management team;
Other work as assigned by the company.
Qualifications:
Master degree or above in clinical medicine
Physician background is a must. At least 3 years clinical doctor experience is preferred
Advanced disease knowledge is preferred
At least 5+ years of experience in clinical research or relevant experience, clinical trials experiences preferred
Solid protocol development/medical related documents, such as protocol synopsis, IB, CSR etc. experience, solid medical monitoring experience and GCP knowledge
IND experience in China and ex-China is must, and NDA experience is preferred
Strategic thinking by actively seeking information to develop optimal clinical development strategy for registration
Excellent verbal and written skills in English
Skills in communication, problem-solving and risk management
Traits:
1. Strong ownership and high engagement
2. Strategic thinking for the drug development strategy
3. Results driven with solid problem solving and time management skills
4. Great interpersonal skills
5. Strong attention to detail. Highly organized
6. Flexible of the working hours to meet the multi-region business needs
