The Senior Clinical Research Physician will take core medical role as scientific leader in drug development within a cross-functional team to design, execute, analyse and interpret clinical studies. Ensures projects (including multiple studies) adhere to Good Clinical Practice and regulatory requirements.
Typical Accountabilities：
1. Leads and/or performs medical documents including but not limited protocol development, IB, TFL, CSR preparation for clinical challenges and governance committee review, as well as health authority interactions.
2. Provide medical guidance and medical supervision during the entire course of clinical trails including but not limited medical monitor of subject eligibility, query, Q&A, protocol deviation log.
3. Manages clinical trials as a medical expertise to deliver study with cooperating with cross-functional partners within the own area of specialty.
4. Provides, as an expert, strategic physician expertise to quantify the benefits, risks, value and uncertainty of clinical trials.
5. Keeps own knowledge of best practices and new relevant developments up to date.
Education, Qualifications, Skills and Experience
Essential
1. Master’s degree in medical discipline or above.
2. Experience as a clinical physician.
3. Experience of management and design of clinical trials.
4. inimum 3 years of experience as clinical research physician in pharma industry R&D.
5. Metabolism or endocrinology or cardiovascular therapeutic area expertise.
Desirable:
1. MD or PhD in scientific discipline.
2. Extensive general medical knowledge.
3. Extensive experience in managing or designing complex clinical trials which require close monitoring.
4. Experience of oncology.