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Global Clinical Head (GCH), AZD7442

Lieu Durham, Caroline du Nord, États-Unis Cambridge, Angleterre, Royaume-Uni Gaithersburg, Maryland, États-Unis Job ID R-092131 Date de publication 10/23/2020

The Global Clinical Head (GCH) - SARS cov2 therapies will be responsible for managing or providing specialist expert support within one principal function, or a geographical area within the span of Medical Science components. The GCH will have significant input into the regional Medical Science strategies and input to the global clinical development strategy and commercial activities. This role also provides leadership or expertise on the components of pricing and value strategy within Clinical Project Teams. The GCH is recognized externally as a thought leader and expert within  SARS cov2 therapies and/or vaccinations and/or monoclonal antibodies for infection.

Are you a clinical research expert ready for new opportunities? Would you like to play a pivotal role in the development of potential medicines? If you are passionate about working in a cross-functional and truly collaborative team – join us!

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, even in the most difficult situations because we are committed to doing the right thing.

As Global Clinical Head you will have a unique opportunity to further elevate the Respiratory and Immunology franchise in one of the world’s most respected bio-pharmaceutical companies.  The role holds a significant development opportunity for the successful candidate whilst contributing to the positive journey that AstraZeneca is on.

Main Duties and Responsibilities

The GCH has overall clinical leadership of one or more global teams and will deliver a portion of the Immunology pipeline. The GCH is also responsible for Medical Scientific strategies for clinical components of the Target Product Profile (TPP), Clinical Development Plan (CDP) and core labelling texts and will provide medical input into commercial activities and the scientific component of the pricing and value strategy.  Within the Clinical Project Team, the GCH has accountability for the clinical, scientific and value content and delivery of the Medical Science components for the Program to time and quality. The GCH will be the team’s voice and representative at the Global Franchise Team that oversees the overall strategy of Immunology.

Typical Accountabilities:

Overall clinical, scientific & value content for an assigned portion of the Program.

Support the Clinical Project Team leading in rapidly implementing new processes and systems and sharing/seeking learning through their Portfolio of Projects.

Medical prioritization of clinical activities.

Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and products in compliance with GCP.

Ensure internal and external peer review of potential study/program design. As available, provide clinical strategic input to in-licensing opportunities.

Broad leadership role across the business.

Support as appropriate within the Program during issue and crisis management as directed by the Therapeutic Area Head for Immunology.

Timely provision of Medical Scientific strategies for clinical components of the TPP, CDP, and core labelling texts.

Essential Requirements:

MD Degree, PhD, and/or PharmD

Demonstrated clinical research expertise with specialist training in Pulmonary medicine/ allergy/ immunology /internal medicine.

Experience in Phase 3 program development and trial conduct, as well as NDA/BLA submissions strongly desired.

Demonstrated ability to lead the development of project strategy and be accountable for project plans, timelines, progress, and outcomes.

Demonstrated ability leading and motivating teams in a matrix environment.

Demonstrated ability to lead, coach, and mentor physicians/scientists.

Significant hands-on clinical drug development experience and scientific credibility.

Experience of Clinical/commercial interface.

Benefit/risk assessment and creating PRMP/ BRATs.

Global regulatory submissions and interacting with major Health Authorities.

Developed/delivered in parallel, composed of multiple complex and large studies (e.g., including but not limited to multinational outcome studies).

Demonstrated ability to cultivate excellent cross-functional collaborations.

Demonstrated ability to effectively communicate at multiple levels of the organization.

Must demonstrate high integrity.

Organize and deliver Advisory Boards with international Key Opinion Leaders (KOLs).

Desirable Requirements

Named Investigator on a number of clinical trials.

Progressed compounds into FTIM and delivered Proof of Principle.

Significant and consistent peer-reviewed publication track record.

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have a seat available and we hope it’s yours.

Where can I find out more?

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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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