Associate Director Oncology Clinical Scientist
AstraZeneca, Gaithersburg, Maryland, us, 20883
Overview / Responsibilities
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 Relationships
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 29-ene-2026
Closing Date 04-feb-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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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 Relationships
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 29-ene-2026
Closing Date 04-feb-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr