Global Clinical Operations Program Director

Join our team in Gothenburg, Sweden, as a Global Clinical Operations Program Director within the Clinical Operations function of Late Stage development in Respiratory and Immunology (R&I) Therapeutic Area. This role offers an exciting opportunity to contribute to our ambition of transforming the treatment of asthma and chronic obstructive pulmonary disease (COPD). As a Global Clinical Operations Program Director, you will work in a global role within the Clinical Operations function of Late Stage R&D (Biopharmaceuticals), supporting one or several products depending on their size and complexity.

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 Global 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 results. 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 case opportunities for review by governance interactions and may act as the lead for cross-functional teams in delivery of various clinical activities and manage improvement or change projects within clinical operations or spanning multiple business areas.

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)  

• 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 projects and the process to identify and solve or raise operational issues. Drive delivery to plan through internal or external partners (alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)). 

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Essential Skills/Experience:

• University degree (or equivalent), preferably in medical or biological sciences or specialty 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.

• Broad clinical operations experience, including but not limited to, program-level oversight of study design, start-up, execution; inspection readiness, license to operate activities, governance interactions, and CRO management  

• Experience from leading clinical projects 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 skills with ability to work effectively with others at all levels of the organization  

Desirable Skills/Experience:

• 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  

At AstraZeneca, we are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way.

So, what’s next?

Are you ready to embrace new and varied opportunities to develop and learn? Join us at AstraZeneca, where we get to develop and grow. Working on things that have never been done before. In return, when great science comes alive, we have the opportunity to get published. Apply now!

Welcome with your application (CV and cover letter) no later than October 16th 2024. We will review the applications continuously so please apply as soon as possible.