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Global Clinical Operations Program Director

Местоположение Миссиссога, Онтарио, Канада Идентификатор вакансии R-220112 Дата публикации 02/19/2025

WHY JOIN US?

At AstraZeneca, we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. With an ambitious goal of delivering 20 new medicines by 2030, there is no better place to make a difference in medicine, for patients, and in society.

Join us on this exciting journey to pioneer the future of healthcare. Our inclusive culture champions diversity and collaboration, and we are always committed to lifelong learning, growth, and development. As part of our team, you'll contribute to groundbreaking advancements that will shape a healthier future for people everywhere. Be a catalyst for change at AstraZeneca, where your work will have a real impact on improving people's lives.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

About the Opportunity

The Global Clinical Operations Program Director (GPD) is a visionary leader at the forefront of Late Stage R&D (BioPharmaceuticals and Oncology) within AstraZeneca. This role requires a comprehensive understanding of oncology strategy, focusing on a single therapeutic area where you will collaborate with experts to lead groundbreaking studies and develop new compounds. The GPD will champion the planning and execution of clinical trials, guiding products from Phase 3 development through to market, and will be integral in shaping business-focused clinical drug development programs that align with AstraZeneca's strategic priorities.

Accountabilities

Lead cross-functional teams of experts in planning and delivering a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning resources, 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).
Manage clinical plans (cost, FTEs, and timelines) in business reporting systems such as PLANIT on behalf of CPT.
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.
Provide 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 contributions to Marketing Applications (aligning closely with other key contributors to submission packages).
Lead cross-functional teams in delivering 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 practices and lessons learned.
Be an early adopter for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiatives.

Essential Skills and Experience

Bachelor's degree (or equivalent) in medical, biological sciences, or related clinical research discipline; an advanced degree is preferred.
Minimum of 10 years of experience in the pharmaceutical industry or similar multinational organizations.
Expertise in project management tools and processes.
Experience in clinical and drug development across various phases and therapy areas.
Ability to adapt and learn across multiple phases and development situations.
Proven track record in leading clinical projects or drug development initiatives.
Skilled in mentoring, developing, and educating staff.
Strong leadership skills to motivate and empower teams.
Proficient in change management.
Ability to implement efficient methods and processes to optimize clinical operations.
Excellent communication, negotiation, and collaboration skills, effective at all organizational levels.
Ability to manage priorities, resources, and project initiatives regionally and locally.
High integrity and ethical standards.
Strong stakeholder management skills.
Adaptable to dynamic environments.

Desirable Skills and 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.

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

#LI-Hybrid

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 authorisation and employment eligibility verification requirements.

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