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AstraZeneca | AstraZeneca Pharmaceuticals LP
Global Clinical Head Renal
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What they do
A Clinical Director directs and manages a medical practice, clinic, hospital, or other clinical setting. Organizes and manages of staff physicians, policy implementation, and ensures that standards for medical care are communicated and maintained.
$134,592 / year median in Maryland
+12% projected growth
Job Description
Global Clinical Head Renal
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working means being entrepreneurial, thinking big and working together to make the impossible a reality! If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
We are hiring a Global Clinical Head (GCH) for Renal in our Late Cardiovascular, Renal and Metabolism (CVRM) Global Development team. This is a key role w 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 CVR and is based in Gaithersburg, M.D or Boston, MA.What you'll do:
The GCH is the most senior medical scientific authority on an asset team and is a core member of the Global Product Team (GPT). The GCH is accountable for all clinical and scientific aspects of the asset(s), including benefit/risk assessment, scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), and core labelling. The GCH develops the project strategy in partnership with the GPL/GPT. The GCH co-leads the Clinical Product Team (CPT) and has accountability for the clinical deliverables.
Accountabilities include:
We are hiring a Global Clinical Head (GCH) for Renal in our Late Cardiovascular, Renal and Metabolism (CVRM) Global Development team. This is a key role w 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 CVR and is based in Gaithersburg, M.D or Boston, MA.What you'll do:
The GCH is the most senior medical scientific authority on an asset team and is a core member of the Global Product Team (GPT). The GCH is accountable for all clinical and scientific aspects of the asset(s), including benefit/risk assessment, scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), and core labelling. The GCH develops the project strategy in partnership with the GPL/GPT. The GCH co-leads the Clinical Product Team (CPT) and has accountability for the clinical deliverables.
Accountabilities include:
- Along with the Global Product Leader, provide scientific strategies for clinical components of the TPP, TPC, CDP, and core labelling
- Accountable for the clinical parts of CPT deliverables
- Responsible for overall clinical and scientific content for the asset
- Work closely with the Clinical Operations lead and ensure the CPT rapidly implements new processes, systems and learning
- Perform medical prioritization of clinical activities within the clinical program
- Single-point accountable leader for the design, delivery and interpretation of clinical studies ensuring ethical and scientific integrity in compliance with AZ policies and Good Clinical Practice
- Basic Qualifications
- Graduate of a recognized school of medicine with an M.D. degree or MBBS or equivalent, with 5 years proven experience in drug development. Specialization in Nephrology would be preferred.
- Demonstrated deep late-stage clinical and research expertise in Renal
- Delivered multiple complex and large studies (e.g., including but not limited to international outcome studies).
- Demonstrated success in influencing global and local cross-functional stakeholders.
- Experience assessing the benefit/risk profile of an asset and creating patient risk management plans.
- Experience with global regulatory submissions and interacting with major regulatory agencies.