Senior Group Director, Clinical Programs, Early Oncology Clinical
The Senior Group Director, Clinical Programs is a key strategic role reporting into the Head of Study Leadership, working closely with the Senior Group Directors for Study Leaders. The role requires stong leadership capabilities to promote, motivate and empower teams. Integral to the position is the line management of Director and Associate Director Study Leaders.
You will provide program-level strategy and oversight for programs containing studies in close-out, implement best practices to support efficient cycle times for Early Oncology Clinical Group (EOCG) studies. As a result, broad experiential knowledge of close-out processes is critical. In this role you will apply experience in delivering process improvements and workstreams to contribute to other improvement initiatives in service of non-drug scorecard objectives. This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of partners both within and outside of AstraZeneca.
You will also serve as a member of the Clinical Programs and Study Operations (CPSO) extended Leadership Team (LT) and provide site leadership and CPSO LT representation at the Gaithersburg site.
Accountabilities
You will have line management responsibilities (Director and Associate Director Study Leaders) including project allocations/resource management, recruitment and selection, personal development and performance management.
You will be a member of the extended CPSO Leadership Team to ensure effective identification and resolution of issues, and departmental objective delivery.
You will be an integral part of the CPSO close-out team supporting best practice and continuous improvement. Specifically, your role will require leadership and oversight of Post Trial Access Program/s (PTAP) identifying improvements and utility for EOCG.
You will lead or contribute to non-close-out continuous improvement initiatives and workstreams.
You will have an active role in developing, coaching and inspiring individuals within the organization.
In addition to the full line management accountabilities, you will undertake responsibilities equivalent to a Senior Director Clinical Programs specifically focused on the portfolio of programs/studies in close-out:
You will plan and deliver the operational components of assigned clinical programs in close-out to final CSR, through to study closed and archived within agreed budget, time, quality and aligned critical metrics.
You will be accountable for planning and leading issue escalation and resolution.
You will be responsible for the quality of close-out delivery and planning information into relevant planning systems.
You will ensure timely compliance with company-wide governance controls (e.g., Sarbanes-Oxley Act of 2002, Delegations of Authority, study attestations, Letter of Assurance, financial system access, Clinical Trial Disclosure).
You will handle external provider results for program/study specific tasks.
Review and operational approval of contracts or work orders.
Engage with internal groups to drive studies efficiently through to study closed and archived.
Skills/Experience
University degree in related field, preferably in medical or biological science. Higher degrees and program management certifications are highly desirable.
At least 10 years global drug development leadership experience with progressive levels of responsibility (ideally including program level); 5 years of experience within clinical function.
Significant line management experience.
Extensive knowledge of the clinical and pharmaceutical drug development process.
Validated ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements.
Significant experience of program management and use of project management techniques in complex projects, including resourcing and financial management.
Strong strategic influencing skills; ability to influence broadly within and outside the organization.
Significant experience and expertise in Clinical Trial methodology with a consistent record to deliver differentiated options based on a sound knowledge of operational delivery.
Ability in problem solving and issues management that is solution-focused.
Extensive experience in driving operational delivery to timelines, cost, and quality.
Experience of leading delivery through collaboration with internal and external providers.
Excellent knowledge of ICH-GCP principles.
Experience in providing clear requirements for external contracts.
Experience in selection of external providers and development/review of contracts.
Demonstrated ability to oversee external providers.
Experience in Oncology clinical delivery.
Experience in a variety of academic/CRO/Sponsor organizations and countries.
Experience across the product life cycle and multiple therapeutic areas.
Experience of early phase clinical delivery is advantageous.
When we put teams in the same room, we ignite ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.
At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs. We champion a mindset of courage where everyone is empowered to step up and innovate. Our dedication to patients and pioneering spirit are truly embedded in our culture.
Ready to make a difference? Apply now!
AstraZeneca 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.
