Global Clinical Operations Program Director

Join the Clinical Operations function of Late Stage R&D

Hays Life Sciences is now looking to recruit a Global Clinical Operations Program Director to join the Clinical Operations function of Late Stage R&D for a 1-year contract assignment at AstraZeneca in Gothenburg or working remotely anywhere in Sweden.

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, from Senior Global Clinical Operations Program Director (Sr GPD), responsibility for oversight of a program of global clinical studies, covering all clinical program deliverables to scope, quality, budget, time, resource and risk, ensuring 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 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 business reporting system, 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.
* Contribute to functional and cross-functional initiatives as Subject Matter Experts
* Mentor, coach and support people development as appropriate.
* Actively participate in networking both within and outside the therapeutic area, sharing best practises and lesson learnt.
* Be an early adopter for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiatives.

Education, Qualifications, Skills and Experience
Essential

* University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
* At least 10 years' experience from within the pharmaceutical industry or similar large multinational organization.
* Proven knowledge of project management tools and processes
* Proven experience of clinical development / drug development process in various phases of development and therapy areas.
* Proven ability to learn by working in multiple phases, TAs and/or different development situations.
* Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
* Ability to mentor, develop and educate staff

Desirable

* Project management certification
* Knowledge of process improvement methodology such as Lean Sigma/Change Management
* Regulatory submission experience
* Proven knowledge of clinical operations
* Experience with development and implementation of digital health initiatives in Clinical Studies