Global Clinical Operations Program Director

hace 2 semanas


Barcelona, España AstraZeneca A tiempo completo

**Make a more meaningful impact to patients’ lives around the globe**:
With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

**Who we are**:
We are united and motivated by our shared purpose - to deliver life-changing medicines. We come to work each day to make a difference - to patients, society and our company.

**What we do**:
We work independently or in partnerships to deliver the next wave of science and address unmet medical needs.

**Why we love it**:
This is the place to make an impact Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.

We have an exciting opportunity to join our team as a **Global Clinical Operations Program Director **within the Clinical Operations function of **Late Stage development in Respiratory and Immunology (R&I) Therapeutic Area**.

Building on a 50-year heritage in respiratory care, our ambition is to transform the treatment of asthma and chronic obstructive pulmonary disease (COPD) by driving earlier, biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. Underpinning chronic lung diseases is an altered immune system. We are following the science of common pathways and underlying disease drivers from respiratory disease into immunology-driven disease areas. The disease areas we’re targeting include rheumatology (including type 1 interferon-driven diseases such as lupus), dermatology, gastroenterology and systemic eosinophilic-driven diseases. Our ambition is to achieve disease modification and durable remission in these diseases for millions of patients worldwide.

**What you’ll do**:
As a **G**lobal Clinical Operations Program Director** you will work in a global role within the Clinical Operations function of Late Stage R&D (Biopharmaceuticals). The span of responsibilities is broad and may support one or several products depending on their size and complexity. The products supported may include studies in all phases of drug development.

The **Global Clinical Operations Program Director** is responsible for oversight of a program of global studies, covering all clinical development deliverables (including aspects of quality, budget, time, resource and risk). The role also involves integrating design, feasibility and operational planning to ensure clinical drug development programs are aligned with priorities and strategy. The role will provide input & support to the Senior Global Clinical Operations Program Director in preparation for new business opportunities for review by governance interactions and may act as the lead for cross-functional teams in delivery of various clinical activities and lead improvement or change projects within clinical operations or spanning multiple business areas.

**Typical Accountabilities**:

- 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 Global Clinical Operations Program Director and Clinical Program Team (CPT)
- Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance
- Lead 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)).

**Essential for the role**:

- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
- At least 10 years’ experience from within the pharmaceutical industry or similar large multinational organization and proven experience of clinical development / drug development process in various phases of development and therapy areas.
- Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development) and proven knowledge of project management tools and processes
- Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives. Ability to mentor, develop and educate staff
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal ski



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