Clinical Operations Program Lead

Role Overview

• The Clinical Operations Program Lead plays a pivotal role to provide input to optimize trial execution, coordinate governance interactions and product strategy.
• This role maintains accountable to the Global & China Project Team (GPT/CNPT) for oversight across a program of global studies covering all clinical development deliverables including aspects of quality, resources, budget, timelines and risks.
• The responsibility spans from clinical program design & planning, through to clinical maintenance activities, data readout and clinical submissions in all phases of drug development.
• Provide program leadership for clinical operational strategy and deliverables: Collaborates with the Sr. GPD or (Associate) Director of Clinical Operations Program in determining possible program design options.
• Provides strategic oversight and feasibility input into the design of the clinical program.
• Collaborates with cross functions to establish strategies and identify synergies aimed at increasing operational efficiency to enable successful study delivery.
• Incorporates digital health and patient centric strategies into clinical studies to balance scientific intention and operational efficiency.
• Provides an accurate budget forecasting, maintenance, and monitoring to baseline, clinical program resourcing, scenario planning, plus overall timelines for trials within assigned program, including setup and maintenance within Company systems.
• Developing and managing of contingency risk plans within each assigned clinical program, including management of program issue escalation and resolution.
• Accountable for ensuring timely compliance with company-wide governance controls.
• Leads operational discussions with external experts/entities, including key opinion leaders, regulatory agencies, and other external collaborators to ensure robust operational design and execution.
• Demonstrates ability to set and lead priorities, resources, performance targets and project initiatives in a global and local environment.
• Responsible for the overall program management of a number of studies delivered by global study leaders, by overseeing quality, budget, resource, timelines and risks, identifying synergies aimed at increasing operational efficiency and providing the team with direction and guidance to enable successful study delivery.

Requirements

• Essential Bachelor degree or above in medical, pharmaceutical, biological science or healthcare
• 8-10 years’ within pharmaceutical industry or similar biotech industry, including 2 years’ global and study-level project management experience
• Proven global experience of clinical development/drug development process across various phases in R&D
• Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Excellent communication skills, including negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
• Demonstrated ability to set and lead priorities, resources, performance targets and project initiatives in a regional and local environment.
• Excellent English speaking and written language abilities
• Integrity and high ethical standards
• Desirable Higher degree e.g. PhD, MD, PharmD
• Project management certification
• Experience of early phase clinical delivery
• Experience of incorporating digital health and patent centric strategies into clinical studies
• Regulatory submission experience
• Experience in development and implementation of digital health and patient centric strategies into clinical studies

Benefits

• 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。