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Disease Area Director, GYN

Location Shanghai, Shanghai Municipality, China Beijing, Beijing Municipality, China Job ID R-104698 Date posted 15/10/2021

Description ​

  • Key Tasks 
    -    China development strategy and plan (including protocols) for all portfolio projects

    -    Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring)
    -    Co-owners of clinical study delivery (with Stats and Clinical Operations)
    -    Development documents (CIB, protocol and CSR, ETC) content owner
    -    Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary)
    -    Forming and running advisory board for portfolio projects; Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design
    -    Responsible for safety program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting 
    -    Oversight of PK/PD programs via clinical pharmacologist to ensure the deliverables
    -    Leading the team in protocol development preparation for review by the Clinical Challenge and Protocol Review Committee
    -    Be a TA lead physician co-leading the China regulatory filing and registration 
    -    Be a TA lead physician leading discussion with regulatory officials on clinical science subjects of compounds in a given TA
    -    Be TA 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 the compounds  
    -    Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences in the TA
    -    Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction 
    -    Be the counterpart of GCL in China for a given TA 
    -    Provide clinical science support to BD and AZ China projects on needed base 

Academic / Professional Qualification

Essential

  • Medical Degree
  • Medical training or TA expert

Technical / Skills Training

Essential

  • Profound Therapeutic Area/Disease Knowledge
  • Patient journey
  • Treatment guidance
  • Deep Compound knowledge
  • Regulatory policy and guidance knowledge
  • Medical monitoring
  • Safety reporting and Risk Management Plan
  • CSP/CSR content, data analysis and data interpretation
  • Presentation & communication skill
  • Excellent analytical and problem-solving skill
  • Strategic thinking End-to-end clinical development process
  • Industry/competitor knowledge
  • Stats knowledge

Working Experience

Essential

  • Minimum 5 years of clinical development experience (at least as clinical research physician for 3 years) in pharmaceutical and/or biotech industry
  • Successfully led (as a compound lead physician) at least on NMC’s China registration development
  • Demonstrated leadership and administrative skills in cross functional project team
  • Big picture with ability to prioritize and focus with attentive to detail and excellent analytical skill
  • Strong and/or extensive networking with KEEs and investigators

【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 
阿斯利康是一家提供平等机会的企业,我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份(如果适用)及任何其他受法律保护的特征而产生歧视。】



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.

10001001 G CDPN R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.