Accountabilities:
1、Clinical development strategy set up: Clinical development plan, medical part of protocol, cross functional alignment.
2、Medical dossier preparation: Medical part of IB, CSR etc.
3、Medical monitoring: Medical review including AE/SAE, protocol deviation, data review. Medical query from PI & CRA.
4、External key stakeholder communication: Communication with external key stakeholder such as TAE, CDE, NMPA etc. with medical support.
5、Cross functional cooperation: Close cooperate with internal stakeholders such as HQ RWE team, PV team, statistic team, strategic team and compliance team etc.
Knowledge/ Academic Qualification:
1、Master’s degree or above in clinical medicine.
Skills:
1、Clinical medical education background preferred
2、Complete GCP training.
3、Fluent both in oral and written English and Chinese
4、Excellent communication skills
5、Familiar with clinical study flow and related policy
Experience:
1、Experience of medical physician role for at least 1 clinical trial is mandatory.
2、More than three years’ experience in R&D pharma. MSA or CRO experience preferred
3、Clinical doctor experience, esp. oncology field experience preferred
Competency:
1、Develop study plan and protocol
2、Knowledge of drug development and clinical trial process
3、Proactive attitude and open minded
4、Facing challenge actively and results driven