Oversight on study-level responsibilities
1 ) Responsible for interacting and communicating with China KOLs for China development
strategy and protocol design.
2) Be responsible for detailed study designs and develop study synopsis and protocol to meet
scientific and regulatory requirements for product registration.
3) Lead study protocol amendment based on cross-functional cooperation to meet scientific
and regulatory requirements.
4) Review essential study documents (e.g., eCRF, ICF, IB, BICR chart, DSUR, CSR, etc) with
appropriate medical inputs.
5) Provide medicalinputs in product TPP, CDP, product positioning and differentiation.
Medical leadership demonstration by physician expertise
1 ) accountable for managing medical monitoring of the clinical trials including review and
approval of subject eligibility and protocol deviation, review of medical data and adverse
events/serious adverse events, medical coding review, medical inputs in data clean and
addressing clinical queries from investigators, and ensure study protocols be implemented
with good medical quality.
2) Oversight the delivery of CRO and related vendors on clinical science matters to ensure
study meets timeline and quality.
3)Provide closely cooperation from medical perspective with study stats on SAP, interim
analysis, patient profile, SAR based on study protocol.
4)Liaise with responsible PV person for safety assessment at individual, study and product
levels as assigned, evaluation of safety signals, and risk mitigation plan development and
5) Provide adequate medical review and inputs in preparation and documents development
for IDMC meeting.
6) Liaise with study pharmacologist on PK/PD programs and conduct medical review on PK
deliverables (e.g., PK SAP, SAR).
7) Be a product and protocol expert, prepare and deliver product and project presentations
at the investigator's meeting, answer medical questions from the investigator and maintain
scientific communication with investigator to ensure continuous adequate understanding of
product and study protocol.
Enhancement on drug registration
1)Provide clinical expertise to the clinical section of regulatory documentations & submission
and address medical questions in regulatory submission, communication and interaction.
2) Lead scientific interpretation on clinical trial data and ensure clinical study report reflects
scientific value with regulatory requirements.
3) Prepare clinical slides as needed and deliver medical presentations to health authority (e.g.,
CDE) communication meeting.
Medical intelligence & Publication
1)Maintain up-to-date medical knowledge and competitive intelligence in the TA and act as
a speaker at internal and external meetings to provide state-of-the-art medical knowledge
of study projects as required.
2)Be responsible for data publication of clinical study, support pre-launch marketing activities
and early market access to the compounds.
Provide clinical expertise and medical assessment to pipeline expansion.
Product lifecycle support
Be responsible for medical evaluation and provide medical leadership in IIS study.
Process standardization and optimization
Involve in the process standardization and optimization for clinical development projects (e.g.,
SOP development and support).
• Bachelor degree or above with major in clinical medicine/related
• 3 year's working experience in medical TA or clinical practice with at least 2 year's experience in clinical study
• At least 2 years' experience in clinical study protocol development and/or medical monitor (Phase 1, 2, 3）