Company

AstraZenecaSee more

addressAddressBoston, MA
type Form of workFull-Time
CategoryManufacturing

Job description

Global Clinical Head - Diabetes and Obesity
At AstraZeneca your innovative discoveries will ultimately have the potential to reach millions of patients in need, all across the globe. That's why we love it - this is the place to make a greater impact.
We are now looking for a Global Clinical Head (GCH) for an exciting Diabetes and Obesity indication in our Late Cardiovascular, Renal and Metabolism (CVRM) development portfolio. This is a key role where you, with your strong leadership skills and drug development experience, will impact and drive development programs in a dynamic global setting.
This role reports to the Vice President, Clinical Metabolism and is placed at our dynamic R&D site in Boston, Seaport Boulevard, MA, US. As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here: Kendall Square Press Release.
What you'll do:
The GCH is the most senior medical scientific expert on an asset team and is a core member of the Global Product Team (GPT). The role holder is accountable for all clinical scientific aspects of the asset, including the benefit/risk of an asset as well as the scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), and core labelling texts. The GCH also provides clinical input into overall project strategy. In some cases, the GCH leads the Clinical Product Team (CPT) and has accountability for the clinical deliverables.
Accountabilities include:
GCH in the Global Product Team
  • Under the leadership of a Global Product Leader, provide scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), and core labelling texts
  • Evaluate the overall benefit/risk of the asset
  • Provide clinical input into product/indication strategy

GCH in the Clinical Program Team
  • Accountable for the clinical parts of CPT deliverables
  • Overall clinical and scientific content for the asset
  • Working closely with the Clinical operations lead, ensure the CPT rapidly implements new processes, systems and learning
  • Medical prioritization of clinical activities within the clinical program
  • 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 AZ policies and Good Clinical Practice

Additional responsibilities:
  • Ensures internal and external peer review of potential study/program design.
  • As available, provides clinical strategic input to in-licensing opportunities.
  • As strategic clinical decision maker regarding patient benefit/risk, final program design and as lead clinical representative in regulatory interactions and interactions with internal senior governance bodies (TALT/LSPC/SET).
  • Engagement and consultation with KEEs. Establishing and nurturing effective networks.

Essential for the role
  • Graduate of a recognized school of medicine with an M.D. degree or equivalent.
  • Demonstrated deep clinical and research expertise in diabetes, obesity or metabolic disease.
  • Significant hands-on late phase clinical drug development experience.
  • Delivered multiple complex and large studies (e.g., including but not limited to multinational outcome studies).
  • 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 leading and motivating teams in a matrix environment, including ability to lead, coach, and mentor junior physicians/scientists
  • Proven track-record of exceptional strategic leadership, in complex organisations and across partnerships
  • Proven teamwork and collaboration skills in a global setting.
  • Scientific credibility internally and externally.
  • Credible in scientific and commercial environments.
  • Fit for purpose business acumen, and insight into payer and reimbursement hurdles globally.
  • Willing to be office-based at our AstraZeneca R&D site in Boston

Desired for the role
  • Global external awareness within 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

So, what's next?
Are you already imagining yourself in the role? Good, because we can't wait to hear from you!
Welcome with your application as soon as possible.
Where can I find out more?
CVRM at AstraZeneca: https://www.astrazeneca.com/our-therapy-areas/cardiovascular-renal-and-metabolism.html
Life at AstraZeneca : https://careers.astrazeneca.com/inclusion-diversity
Why AstraZeneca?
AstraZeneca is a global, innovation-driven biopharmaceutical company proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity. There's no better place to see what science can do.
Date Posted
15-Dec-2023
Closing Date
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 (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). 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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
Refer code: 7433751. AstraZeneca - The previous day - 2023-12-25 08:06

AstraZeneca

Boston, MA
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