Job Code: CNCD04
Department Clinical Development – Medical Science
Reports to: Medical Director, Asia
Location: Taicang Office/ Remote, China
Study Physicians design and ensure successful conduct of clinical studies with highest integrity in China and review study results. Study Physicians are core members in Product Clinical Development Team and responsible for the compound’s China development strategy and plan. Study Physicians are also responsible for supporting the global team on compound global development strategy and global study conducting.
- Ensure successful conduct and integrity of all in-scope clinical studies (i.e., provide medical monitoring).
- Co-own clinical study delivery (with Clinical Operations and Stats).
- Develop documents (IB, protocol and CSR, etc.); content owner.
- Analysis and interpretation of clinical study results in partnership with Stats, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary).
- Form and run China protocol review committee.
- Form and run advisory board for portfolio projects.
- Is responsible for interacting and communicating with China KOLs for China development strategy and protocol design.
- Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting including updating safety profile in the Investigator’s Brochure, Risk Management Plan, DSUR, etc.
- Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables.
- Set strategic direction for addressing medical issues in regulatory submission and communication/interaction/
- Is a TA clinical science expert in supporting China regulatory filing and registration
- Isa TA clinical science expert in leading discussions with regulatory officials on clinical science subjects of a given project.
- Oversee the delivery of CRO company and related vendors to ensure the study meets the timeline and ensure quality.
- Interface with CRO study teams and study related vendors on clinical sciences matters.
- Provide consultation to clinical operation colleagues on protocol design questions and answer protocol related questions from site investigators.
- Medical degree, physician license is preferred.
- At least 3 years of clinical development experience (at least as clinical research physician for 1~2 years) in pharmaceutical and/or biotech industry or CRO company. Clinical practice in TA.
- Medical expertise in related therapeutic areas.
- Good GCP knowledge and deep clinical trial related knowledge.
- Experience of study design and drug development plan.
- Regulatory guidance for the TA.
- Experience with medical monitoring, safety reporting and Risk Management Plan.
- Familiar with CSP/CSR content & data analysis.
Skills and Attributes:
- Fluent English and Chinese, written and oral.
- Good presentation & communication skills.
- Can work independently and also as a good team player.
- Demonstrates leadership in cross functional work and can adjust to a high-speed environment.
- Ability to prioritize and focus with attention to detail and excellent analytical skills.