Remote within Sweden
Global Clinical Operations Program Director
Location: Fully Remote but need to be based in Sweden
Duration: 1 Year with possible extension
Role and Tasks
My client who is one of the leading organizations in the pharmaceutical field is currently looking for a Global Clinical Operations Program Director to join the Clinical Operations function of Late-Stage R&D
The Global Clinical Operations Program Director (GPD) is a core global role within the Clinical Operations function of Late Stage R&D (Biopharmaceuticals and Oncology). The span of responsibilities is broad and may support one or several products depending on their size and complexity.
The products supported will be in Phase 3 development or on the market, but the program may include studies in all phases of drug development.
The GPD has a delegated, Senior Global Clinical Operations Program Director (Sr GPD), responsible for oversight of a program of global clinical studies, covering all clinical program deliverables to scope, quality, budget, time, resource and risk, ensuring the new innovative design and delivery models are used appropriately.
The role involves integrating strategy, design, feasibility and operational planning to ensure clinical drug development programs are aligned with priorities and strategy.
The GPD will develop the core clinical program components for governance interactions with the oversight of the Sr GPD.
The GPD acts as the lead for cross-functional teams in the delivery of clinical activities assigned.
The GPD may provide project leadership for cross-functional clinical submission teams in support of regulatory marketing applications and post-registration product maintenance deliverables.
Additionally, the GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas.
Typical Accountabilities and Responsibilities (delegated by Sr GPD)
Lead cross-functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk.
Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr GPD and Clinical Program Team (CPT).
Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.
Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, quality, feasibility, risk).
Lead cross-functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications, maintenance support for regulatory interactions and reports and inspection readiness.
Lead large or complex deliverables and the process to identify and solve or escalate operational issues. Drive delivery to plan through internal or external partners (alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs).
On behalf of CPT, responsible for managing clinical plans (cost, FTEs and timelines) in a business reporting systems, such as PLANIT.
Internal Job Description
Act as AZ point of escalation for study teams for external (e.g. CRO) partners for externally managed/outsourced studies as appropriate
Responsible for leadership and program management of non-drug project work as assigned, e.g. cross-functional improvement/change initiatives.
If you wanna know more about this opportunity, please do get in touch with me.
Phone: +44 20 3763 9535