Associate Director Oncology Clinical Scientist

Typical Accountabilities:
• Plans and leads the delivery of all components of a clinical development project

• Leader of a clinical development team, key player during the whole process, and responsible for consistency during the course of the project

• Develops recruitment strategies, and the delivery of the approved Clinical Development Protocol

• Works with Line Managers to identify resource need and secure resources from various departments to ensure flexible and timely formation of the Clinical Study Teams and progression of deliverables

• Forecasts and day-to-day management of timelines, budget, materials and development of detailed project plans and feasibility assessment

• Leads and implements globally agreed Clinical Development strategies including process and technology

• Plans and leads activities associated with audits in liaison with CQA; contribute to regulatory inspection strategy teams as required

• Develops & manages contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate

• Leads preparation and delivery of clinical development deliverables

• Establishes and maintains key interactions with stakeholders

• Plans, leads and ensures appropriate training is achieved at Investigator/monitor meetings

• Coordinates and/or contribute to timely delivery of SD components of submissions to regulatory authorities (e.g. CSRs, CTDs, INDs, IND annual reports)

• Leads and optimizes the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate skill centre managers

• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration


Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) -


What is the global remit? (how many countries will the role operate in?):
• 2 or 3 countries at a minimum of 40% of time


Education, Qualifications, Skills and Experience:
• Essential: Bachelor’s degree in biological science or healthcare-related field; Experience in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes; Demonstrated leadership ability in a team environment; Experience in project management methodologies; Advanced knowledge of the clinical study and drug development processes, GCP/ICH guidelines; Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills; Budgetary and resource management planning experience; Willingness to travel both domestically and internationally; Excellent knowledge of spoken and written English; Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

• Desirable: Effectively plans, coordinates and facilitates delivery of team objectives; Demonstrates appropriate Project Management skills; Demonstrates operational expertise in risk management and contingency planning; Has an appropriate understanding of disease state and familiarity with the latest research and thought leaders; Demonstrates an extensive knowledge of the clinical study and drug development process, GCP/ICH guidelines and SOPs; Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of AZ and SD systems/software in an e-enabled environment; Demonstrates conceptual, analytical and strategic thinking; Effective problem and conflict resolution skills and proven team focus; Demonstrates good team skills including cooperation, concern for impact, willingness to learn from others, and sharing of relevant information AstraZeneca Job Description – Study Delivery Leader

Key Relationship to reach solutions:
• Internal (to AZ or team): Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate
• External (to AZ): External service providers; Marketing Company personnel

Date Posted

Closing Date

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