- Beijing, Shanghai, Nanjing|| ||
- 5-10 years
- Full time
Description of position:
Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration
May provide pivotal medical input to new drugs, including but not limited to recently acquired assets, and to support drug development.
Support in all medical, scientific, strategic and clinical matters both Project Teams and drug development programs from lead compound identification to product registration and launch
Provide medical, scientific and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure, communication with regulatory authorities, clinical trial synopses, clinical trial protocols, clinical summaries, Clinical Study Report, with the support of other R&D functions and in line with IDP, RFIs/RFPs
Provides medical expertise on clinical drug development throughout life-cycle of compound:
Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material.
Provides continuous medical monitoring during study conduct, answers site questions oninclusion/exclusion criteria or other protocol questions, evaluates and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events, and provides medical expertise to project teams during life-cycle of study.
Provides therapeutic training relevant to specific study to the project team or site PI
Attends and/or presents at investigator, internal and external project team meetings.
Defines criteria for assesses and evaluates protocol deviations and recommends on actions to be taken. Assumes responsibility for ethical, e.g. medical, aspects of study.
Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients.
Master degree above, Medicine, Clinical is must.
Fluently English is must.
More than 5 years experiences in clinician or clinical R&D are must.
Positive attitude, drive to do your best, learning attitude
Trustworthy and reliable for strong sense of responsibility and carefulness.
Patience and meticulousness is prefer.
We invent personalized medicines with global impact, and turn innovation in China to life saving therapies for the world
Tel: +86 25-58251030
Office address: 73 Tanmi Road Block D-2, 3rd Floor Jiangbei New District, Nanjing