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 area
Significant 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 globally
Line 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 locations
Experience 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!
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.