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    Global Clinical Operations Program Director - Baltimore, United States - AstraZeneca

    AstraZeneca
    AstraZeneca Baltimore, United States

    3 weeks ago

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    Description


    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

    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 and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

    Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work.

    We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

    Do you have expertise in and a passion for global Clinical Program Management? Would you like to apply your expertise to impact the development of an exciting oncology portfolio in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you

    AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases.

    But we're more than one of the world's leading pharmaceutical companies.
    Join a dedicated Oncology team in Haematology that's growing fast and building a strong track record of success.

    We have multiple indications and many high-quality molecules at all stages of development – but we see even more potential.


    Following the recent acquisition of Gracell Biotechnologies we are looking to expand our team bringing in individuals with Clinical Operations experience in Heamatology Cell Therapy.

    Oncology is driven by speed. We make bold moves at the cutting edge. Transforming molecules to change the practice of medicine. Here it's our scale, agility and passion that makes sure we deliver fast, every time.
    Haematology sits within our broader Oncology Research & Development organization.

    We take an inter-disciplinary approach including novel biomarkers, AI, novel endpoints and cutting-edge trial designs to shape the future of our business and Oncology.

    With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next.

    Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.

    What you'll do
    The Global Clinical Operations Program Director (GPD) is a core global role within the Haematology R&D Clinical Operations function. The span of responsibilities is broad and may support one or several products depending on scope and complexity. The products supported can be in any phase (Early and Late), of development or on the market.

    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 operations 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, as well as potential line management of clinical operations personnel.

    Essential for the role
    Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred e.g. PhD, MD, PharmD
    Experience from within the pharmaceutical industry or similar large multinational Clinical Research organizations.
    Experience in Oncology Phase 1 dose escalation and/or registrational Phase 3

    Haematology Cell Therapy

    trials as a global study leader or Oncology Program Manager
    Proven experience in clinical development/drug development process in various phases of development and therapy areas.
    Proven knowledge of project management tools and processes
    Proven ability to learn by working in multiple phases, TAs, and/or different development situations.
    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 for the role
    Line management experience is desirable
    Experience with development and implementation of digital health initiatives in Clinical Studies
    Great People want to Work with us Find out why:
    GTAA Top Employer Award for 10 years
    Top 100 Employers Award
    Canada's Most Admired Corporate Culture
    Learn more about working with us in Canada
    View our YouTube channel
    Are you interested in working at AZ, apply today

    AstraZenecais 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

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