Associate Director, Early Clinical Research Scientist, CVRM

Job Description: Associate Director Early Clinical Research Scientist, CVRM

Location: Office based hybrid role in Gaithersburg MD

Are you a scientist with clinical research experience in cardiovascular and/or kidney disease? Join AstraZeneca and be part of an impactful team of cross functional clinical research professionals translating scientific discoveries into early phase clinical development programs across a wide range of chronic and debilitating diseases.

AstraZeneca, is dedicated to being a great place to work with an inclusive and diverse team of amazing colleagues who work in a dynamic collaborative work environment. We are dedicated to improving the healthcare and quality of life for patients; developing innovative therapies that address unmet clinical needs and that provide clinicians with novel evidence-based treatment options that will enable them to optimize patient care.

Who We Are:

In Cardiovascular, Renal & Metabolism (CVRM), we are investigating the drivers of CVRM disease progression through ground breaking scientific methods and data-driven drug discovery and development approaches. In this context, the Early Clinical Development team are investigating varying drug modalities from a rich CVRM portfolio across cardiovascular and kidney disease patients.

Early Clinical Development is part of the Early CVRM organization, and is where science meets the patient with a focus upon delivering innovative programs, accelerating human target validation, while collaborating closely with late clinical development and regulatory colleagues who guide pivotal phase 3 clinical studies. We are a team of passionate clinical scientists and physicians who collaborate broadly to establish strategies, design innovative phase I through phase IIb clinical trials, develop and validate novel endpoints, and translate scientific ideas in to a proof of concept in targeted patient populations.

We are looking for a clinical development scientist with clinical research experience in cardiovascular and/or kidney disease. Your ambition to improving patients’ lives will involve you in a team working in a collaborative environment, driving the clinical development of novel innovative therapies in CVRM diseases. This role enables you to work at the forefront of early clinical and translational research in CVRM.

What you will do:

As an Associate Director, Early Clinical Research Scientist your core accountability will be scientific support for the development and maintenance of clinical strategies based upon your established expertise including the latest thinking about mechanisms of disease, diagnostic approaches, current treatment options, drug development trends, and regulatory requirements in relevant disease and therapeutic areas. You will contribute to early phase clinical trials and related clinical research projects for potential therapies that are targeting cardiovascular and kidney diseases, as well as serving as an expert on the design, conduct, monitoring, data interpretation, and reporting of these studies. Additional tasks include supporting regulatory documentation, liaison with discovery scientists, regulatory, clinical and commercial colleagues, developing and managing external collaborations, and developing a deep knowledge of the literature pertaining to the product(s) under development. You will also work on cross-functional teams within our early clinical development group and across the broader early CVRM organization that are framing our strategies and development plans for potential therapies that are targeting major metabolic disorders, given that these disorders intersect with cardiovascular and kidney diseases and influence disease progression.

In this role, you will contribute to cross-functional project teams with multidisciplinary professionals from a diverse range of geographic locations. We will rely on you to:

• Contribute to the design and operational implementation of early-stage clinical projects ensuring programs under your purview are scientifically meticulous, clinically sound, operationally successful, and adhere to GCP and regulatory requirements.
• Collaborate closely with other groups within early CVRM to provide expert clinical input into pre-clinical scientific activities such as target selection, lead generation and optimization, clinical pharmacology and in vivo/in vitro studies.
• Work collaboratively with highly capable teams of physicians and clinical scientists who design scientifically thorough clinical studies aligned with pre-clinical scientific findings and development plans for each potential therapy, while ensuring seamless transition of early clinical programs to late stage development.
• Assist with the preparation, review and maintenance of project documents including those for regulatory authorities.
• Contribute to interaction