Physician – Director – R&D China R&I
Clinical Research Physician, Lead Inhaled Respiratory Portfolio (Shanghai, China)
Responsible for R&D China inhaled respiratory products’ clinical development strategy and execution plans. A core member of R&D China R&I TA leadership team responsible for the scientific and medical strategy for inhaled respiratory products. Support relevant China product teams (CNPT) and collaborations with corresponding (global) clinical product teams (CPT), global product teams (GPT), and franchise teams, for the development of AstraZeneca's compounds to support registration in China.
Responsible for China clinical development leadership of in-scope programs. Work with the global clinical head (GCH), global clinical program leaders (GCPL), and global clinical research physicians to provide strategic and tactical medical & scientific inputs to relevant China clinical development programs. Overall responsible for the design, conduct, monitoring, data interpretation and reporting of China-led clinical trials of inhaled respiratory products.
Provide clinical science technical leadership and mentoring to study physicians and medical scientists.
China development strategy and execution plan for all inhaled respiratory programs
- Provide medical and scientific leadership in in-scope China clinical development programs of medicines targeted at indications in the field of respiratory disease
- Ensure successful conduct and integrity of all in-scope clinical studies. Co-owner of clinical study delivery (with Biometrics and Clinical Operations Leads)
- Development of documents (CIB, protocol and CSR, etc.) as a content owner
- Analysis and interpretation of clinical study results in partnership with Biometrics Lead, Clinical Operations and Safety (as well as Clinical Pharmacologist if necessary)
- Forming and running advisory board for relevant programs; responsible for interacting and communicating with China KOLs for China development strategy and protocol design
- Oversight of program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting via safety physician
- Oversight of China PK/PD programs via clinical pharmacologist
- Lead the China team in protocol development preparation for review by the PRC and DRC
Setting strategic direction for addressing medical issues in regulatory submission, and communication/interaction on relevant programs
- Lead physician co-leading the China regulatory filing and registration
- Lead physician leading discussion with regulatory officials on clinical science subjects
- Lead physician providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators
- Liaise with MA and BD to support pre-launch marketing activities, publications, conferences and early market access to in-scope compounds
- Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences in relevant areas. Disseminates new information within CNPTs and CPTs/GPTs.
- Liaise with the internal and external medical community to follow developments within areas of expertise
Line management responsibility for medical scientists, delivering the performance management and guiding the professional development of direct reports
Provide clinical science support to BD and AZ China projects on as-needed basis
Be the counterpart of GCPLs in China for in-scope compounds.
- Fully qualified physician (MD or MD PhD [preferred]) with pharma industry experience in late stage clinical drug development. In addition, experience in early stage clinical drug development is preferred.
- Significant experience (> 5 years’ experience) in the design, execution and interpretation of clinical trials. Background in respiratory and/or inflammatory disease areas; but other specialties could also qualify.
- Thorough understanding of China drug development and good understanding of China regulatory environment. Drug development experience in China preferable.
- Good verbal and written communication skills in English and Chinese
- Good teamwork and collaboration skills
- Able to travel nationally and internationally
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.