Clinical Development Head - BioPharma

Jing'an, Shanghai
Permanent
Full-time

2 months ago

Biopharma Clinical Development Head is a SET-2 role and take the overall accountability to the Head of R&D China for biopharma portfolio delivery and safety science in China, including development of scientific strategy, creation and implementation of Clinical Development Plans of Biopharmaceutical therapeutic area. The role is an important interface representing R&D China with internal and external stakeholders in the responsible TA. The role also has line management responsibility for development physicians/scientists in Biopharmaceutical TA. This role will also serve as the co-chair of Project Review Forum of biopharma TA and member of China Portfolio Management Committee.Typical Accountabilities

Lead to develop China Biopharma drug development strategy, and contribute to R&D China scientific strategy
Responsible for planning and execution of all biopharma portfolio projects, serve as a member of China portfolio management committee (PMC) for biopharma TA decision making
Accountable for the successful delivery of biopharma portfolio, co-chair China Biopharma Project Review Form to ensure the quality and speedy delivery
Owner of development documents (CIB, protocol and CSR, ETC) with China content
Oversight of Safety and PK/PD programs at portfolio level to support the portfolio project delivery
Oversee TA clinical science, Translational medicine and Safe science functions, drive the performance for project delivery and any other initiatives
Build and develop a strong Biopharma clinical development team, foster a life-learning culture, coaching culture, develop physicians’ capability, and support their career development
Build and develop strong CNPT (China Product Team) in biopharma TA
Lead to ensure effective collaboration with global biopharma clinical development teams, to foster knowledge sharing, global projects deliver and talent exchange
Build and strengthen the alliance with key external partners including the academia institutes, and KOLs

Education, Qualifications, Skills and ExperienceEssentialAcademic / Professional Qualification

Medical Doctor Degree
Global drug development experience

Technical / Skills Training

Deep biopharma therapeutic area knowledge
Sufficient regulatory knowledge for BioPharma TA and necessary Statistics knowledge
Insight on biopharma research and development in China
Broad network with Chinese KOLs and investigators
Deep knowledge of CSP/CSR development and study data interpretation
Excellent in communication and presentation, both in English and Chinese
Strategic thinking and prioritization
Strong problem solving and analytical skills
Strong leadership in building effective teams, developing talents, etc
Ability in fostering collaboration, life learning, inclusion & diversity cultures

Working Experience

Minimum 10 years clinical development experience in pharmaceutical companies
Minimum 5 years on biopharma TA leader role (

= Director level position) with successful delivery track record of drug development and registration * Rich NDA submission experience

Rich Medical monitoring experience

Desirable

Experience in regulatory agency interaction
Philosophy Doctor degree

Date Posted 03-7月-2025Closing Date 29-6月-2026AstraZeneca 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 authorization and employment eligibility verification requirements.

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