Senior Director, Study Management Late Oncology (2524761804)
The Senior Director, Study Management (SDSM) Late-stage Oncology will strengthen our TA alignment. This role combines deep TA/tumor knowledge, combined with strong leadership and excellent partner management, to build and implement strategies to achieve excellence in an aligned organization concentrating on Oncology focus areas to optimally deliver our clinical studies.
As a SDSM, you develop strategy and tactics to deliver studies within a therapeutic area in a consistent and efficient way, and ensure sharing of knowledge and TA upskilling across resources allocated to the projects within the therapeutic area of your responsibility.
Additionally, the SDSM will take a senior leadership role for hub related initiatives in and across locations.
What youll do:
You will collaborate with Director Clinical Development (DCD)/Associate Director Clinical Development (ADCD) and Directors, Study Management (DSM), accountable for timely, within budget and quality delivery of studies from Study Hand-over to Clinical Study Report.
You will ensure right level of TA expertise and knowledge sharing and consistent ways of working across study management teams working within aligned TA, and across Oncology and other TAs.
You will be the main point of contact for DCD/ADCDs and other partners within assigned TA to ensure Study Management has a good understanding of the TA priorities, is aligned strategically and has a shared vision with TA project team. Additionally, this role will share their insights with the project team (DCD/ADCD).
You provide strategic leadership to the Study Management organization (SMO) in the assigned therapeutic area to drive projects and performance.
You work together with the Early Oncology leadership as appropriate
You are the point of escalation for quality issues and inspection readiness
You act as a study management resource to DCDs/ADCDs during the New Opportunity planning and governance phase.
You support delivery, as appropriate, through the submission and approval phase of a project
As member of Study Management Leadership Team :
You work with closely with the Leadership Team, responsible for timely and high-quality delivery of the studies assigned to Study Management late Oncology
You drive an environment of global standardization and continuous improvement
You help develop and maintain global operational delivery models and mid and long-term strategic workforce planning
With other members of the Leadership team and key customers, you develop and deliver performance targets and metrics for the operational study delivery ensuring effective risk planning and open visibility of issues escalation pathway
You ensure the SMO has the capability and resources required to deliver assigned studies, and build Study Management capability and organization for the future
You drive and create a culture that feeds courageous, entrepreneurial, creative and coordinated behaviors
You contribute to the overall late Oncology performance
You lead a significant project or non- drug project deliverables that contribute to overall AZ business success
You may be responsible for the role of the location lead for study management to collaborate with significant local departments - HR, Finance, IT, compliance, facility management which is needed for the maintenance of the organization and determination of local budget
As a Functional Manager:
You attract, recruit, develop & retain top talent
You lead and support change
You develop, coach, mentor, motivate and support SMO employees to achieve their fullest potential
You ensure performance management and personal development of employees
You comply to ethics, policies and standard procedures
You are the line manager of the Associate Directors Study Management
Essentials for the role:
University degree MSc or equivalent preferably in life science
At least 5 years’ experience in study management including 3 years in assigned TA
At least 10 years Pharmaceutical Industry experience in Clinical Development and Study Operations
Comprehensive knowledge of clinical and pharmaceutical drug development process with at least 10 year’s experience in this area.
Excellent stakeholder management skills
Validated line management and leadership expertise, with at least 3 years experience as a line manager
Shown development of others, identifying and providing opportunities to improve the capabilities of other people
Risk and crisis management experience
Background of high professional achievement and willingness to bring this out in others
Leads change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and make valuable contributions to the business
Ability to set and run priorities, resources, performance targets and project initiatives in a global environment
Ethics: Maintains high standards, including a commitment to AstraZeneca values, policies, and employment principles and policies.
Cultural Awareness: Is aware of and sensitive to cultural differences and their impact on communication, expectations and performance.
Effective in leading and being a member of teams, both locally and internationally