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Global Clinical Operations Program Director

Posted date Feb. 21, 2025
Contract type Full time
Job ID R-220402
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Why choose AstraZeneca Spain?

AstraZeneca Spain is a rising force in our global business. With headquarters in Madrid and our global hub in Barcelona, we’ve become an important international centre of excellence in the fight against critical disease. Boasting vibrant universities and business schools, the Barcelona ecosystem is a place where scientists can thrive. We attract a diverse workforce from across the globe, shining a beacon for innovation in a country that’s committed to clinical development.

We invite you to bring your talents to Barcelona where our respiratory medicine R&D and Global Marketing centre offers opportunities in R&D, IT, Commercial and HR. Or join us in Madrid and shape our growth in our BUs (Respiratory, Oncology & CVRM ), and a range of Corporate functions. Additionally, you can find sales roles throughout the country. Together, we’re contributing to a world-leading pipeline of therapeutics and delivering life-changing medicines to patients.

Who do we look for?

Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca Spain, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Alongside technical expertise, colleagues have the resilience, energy and collaborative mindset to change lanes, work with different teams and start projects from scratch.

Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Madrid or Barcelona, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.

Success Profile

Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.

Diverse collaborators

This is a speak-up culture that values collaboration. You’ll proactively bring your unique perspectives, experiences and skills to the table and seek the same from others. With our international team composition and the need for fast-paced collaboration, you’ll always be building new connections with colleagues.

Cutting-edge innovators

When you join us, you’ll be part of a team that embraces digital technology and data to transform the way we work and the work we do. Every day, you’ll help make history, empowered to ignite your creativity and build something enduring.

Resilient trailblazers

Here, the answers aren’t always available. So, you’ll need to bring a fearless, self-starter mindset to navigate uncharted territories. You’ll harness your ceaseless energy to discover and make the necessary connections with colleagues to shape the future and achieve maximum impact.

Agile movers

Seize ownership and excel with autonomy to enjoy the constant rush of ground-breaking discovery. Your ability to anticipate sudden shifts and adapt swiftly will prove critical as you make your mark in an environment that rewards initiative and resilience.

Responsibilities

Job ID R-220402 Date posted 02/21/2025

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

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 scope 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. On behalf of the Senior Global Clinical Operations Program Director (Sr GPD), the GPD provides strategic operational leadership and oversight of a suite of global clinical studies within a program covering all clinical program deliverables, covering all clinical operations 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 produce business-focused clinical drug development programs that align with priorities and strategy. The GPD will develop the core clinical operations components for governance interactions with the oversight of the Sr GPD. The GPD may also act as the lead for cross-functional teams in delivery of clinical program team (CPT) 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.

Responsibilities

  • 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)

  • On behalf of CPT, responsible for managing clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT

  • Lead large or complex deliverables and the process to identify and solve/escalate operational issues and drive delivery to plan through internal or external partners (Alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)).

  • Act as the 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

  • Provide project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package)

  • Lead cross-functional teams in delivery of assigned clinical program team (CPT) activities

  • 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 organizations.

  • Proven knowledge of project management tools and processes

  • Proven experience in 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

  • Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives

  • Skilled & experienced in change management

  • Ability to look for and champion more efficient and effective methods/processes of delivering clinical operations components focusing on key performance metrics around reliability, productivity, cost, and quality

  • Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization

  • Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment

  • Integrity and high ethical standards

  • Excellent stakeholder management skills

  • Adaptability

Desirable

  • Project management certification is desirable but not mandatory.

  • Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory

  • Regulatory submission experience

  • Proven knowledge of clinical operations,

  • Experience with development and implementation of digital health initiatives in Clinical Studies.

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.

50056654 F CDGE R&D Oncology

Reasons to Join

Thomas Mathisen

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Sales Representative Oslo, Norway

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Christine Recchio

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Sales Representative California, United States

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Stephanie Ling

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

Sales Representative Petaling Jaya, Malaysia

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

What we offer

We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, inclusivity, balance and sustainability. Discover what a career at AstraZeneca could mean for you.

An award-winning company

We're passionate about being a great place to work, and 84% of our employees would recommend us as an employer. We've been recognised as a Top Employer in Spain, an EFR Family Responsible Business, and we achieved third place in Forbes Spain's Top 50 Best Places to Work list.

Inclusive environment

Diversity and inclusion are embedded in everything we do, and our different views, experiences and strengths enrich our culture. There's no salary gap at AstraZeneca, and the number of female employees has increased by four per cent over the last three years. We've also made all positions fully accessible.

Work-life balance

Your wellbeing means a lot to us, and we're here to support you through all of life's ups and downs. That's why we offer an unpaid leave policy, annual leave, reduced-hours timetables and a host of benefits, including a retirement plan, long service award, and health and travel insurance.

Sustainability initiatives

We're committed to harnessing the power of science to become a more sustainable business. We've reduced our carbon footprint by over 9,000 kg of CO2 over the last two years, and we lead the European GoGreen Project, which aims to introduce environmentally friendly options in our fleet of corporate vehicles.

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.