Position Title：Physician/Senior Physician
Department：Clinical Development
Location：Shanghai
Position Summary
Support clinical development planning and execution to align with customer’s clinical trial project request and quality standard. By interacting with various key functions (for example clinical operation, biometrics, quality assurance and pharmacovigilance)。 This position will provide clinical expertise to conduct and manage project related medical monitoring. He/she shall deliver high quality clinical scientific services by providing medical input to protocol, contributing to protocol adaptation, conducting medical writing, and relevant activities. He / she shall also build and maintain good medical science relationships internally with all functional lines within the company and externally with KOLs and investigators. He / she will have the exposure to different project teams, diverse portfolio of clients, as well as various therapeutic areas.
Key Responsibilities
Assist clinical development planning and execution to serve the clients
Support to oversee clinical development activities in medical monitoring and medical writing
Play key role in providing medical and clinical inputs to the projects, as well as insight into the process.
Provide medical review and clinical input on clinical protocol design, protocol adaptation, and monitoring on clinical trial execution
Provide medical and scientific input of client’ inquires and discussion
Liaise with clients to support study design and site capabilities
Ensure the physical and mental wellbeing of subjects is undiminished during the study
Responsible for ensuring that the clinical trial is conducted per clinical development plan and all applicable regulations
Act as the primary client’s contact for medical and medical safety monitoring.
Contribute to medical writing on clinical study related documents, including IB, study synopsis, protocol, CSR or other relevant documents.
Perform literature searches as needed for drafting document content. Interprets literature information
Attend study initiation meetings; Liaise with clients regarding study design and site capabilities
Assist clinical operations and client managers with sponsor visits
Review pre-study physical examination and lab data to ensure subjects recruited to meet study inclusion exclusion criteria
Help to develop and administer budgets, resource plans and performance objectives for the clinical development function
To assist the training for junior staff, and colleagues regarding therapeutic area knowledge
Closely monitor relevant therapeutic area movement, clinical research updates and maintain sound medical and scientific capability.
Education and Key Competency Requirement
Professional Experience & Education Requirement
Minimum M.D degree or other life science degrees (or equivalent); clinic practice is required
Minimum 4 years of experience as physician or medical manager in biopharmaceutical industry
Rich working experiences in medical monitoring
Rich working experiences in providing medical and scientific advices on clinical trial protocol design and other clinical development strategies
Key Competency Requirement
Ability to think critically and scientifically
Strong organizational, interpersonal, self-motivation, and high personal integrity
Ability to determine and prioritize workload
Ability to communicate professionally and courteously with clients
Proactively seeks out process improvements, efficiencies, and innovations
Well-developed of time management, communication, presentation, analytical and interpersonal skills
To have a detailed knowledge of the regulatory guidance for ICH/GCP
Strong though leadership contributing to project outcome
Facilitation and influence skills
Project management skills and effectively manage timeline and multiple tasks
A strategic thinker with strong problem Solving skills
Excellent English written and verbal communication skills
Proficient in the use of relevant office applications Experience in Oncology will be desired
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