Global Clinical Head, Respiratory

Are you passionate about science and experienced in Respiratory? Do you possess strategic and operational leadership skills? Then join us! We are hiring for a Global Clinical Head, Respiratory to be based in our Gaithersburg, US location.

AstraZeneca’s pipeline of innovative medicines is consistently growing within Respiratory and Immunology(R&I). Within R&I we take innovative regulatory approaches to bring these life-changing treatments to those who need it – working across our late-stage development pipeline and the business as efficiently and effectively as possible.

The Global Clinical Head (GCH) is the most senior medical scientific expert on an asset/product/indication team and is a core member of the Franchise Team (if applicable) and/or the Global Product Team (GPT).

This role will report to the Vice President Clinical Respiratory.

This person will be accountable for all clinical scientific aspects of the product/asset, including the benefit/risk of a product and/or asset as well as the scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), Clinical components of regulatory documents and core labelling texts.

Provide clinical and medical expertise input into overall project strategy. Will have accountability for the clinical deliverables i.e. clinical studies, clinical components of regulatory submissions etc to time.

Serve as the single point of contact for TA-Heads and R&D leaders for clinical and scientific components of the product and/or indications.

Essential for the Role

An MD, or other equivalent medical degree from an accredited university with specialty training in Respiratory or related area.7 years’ relevant experience within the respiratory space, including late-phase drug development experience.Demonstrated deep clinical and research expertise in appropriate disease areaSignificant hands-on late phase clinical drug development experience.Developed/delivered multiple complex and large studies (e.g., including but not limited to multinational outcome studies).Scientific credibility internally and externally.Demonstrated success in influencing functions outside of clinical and across geographies.Experience of benefit/risk assessment and creating patient risk management plans.Experience of global regulatory submissions and interacting with major regulatory agencies.Demonstrated ability to successfully lead, coach, and mentor other physicians/scientists.Proven teamwork and collaboration skills in a global setting.Credible in scientific and commercial environments.Fit for purpose business acumen, and insight into payer and reimbursement hurdles globallyLine management experience.

Desirable for the role

Global external awareness within the therapeutic area.Global regulatory awareness.Ability to travel nationally and internationally.Experience in several organizations and geographic locationsExperience of working with Market Companies to deliver studies/projects.Experience of clinical/commercial interface.

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 groundbreaking methods and bringing unexpected teams together.

We are eager to know more about you. If you are interested in learning more about us, apply now!

Date Posted

14-Nov-2024

Closing Date

20-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.